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Trial record 43 of 239 for:    (armodafinil)

Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT00481195
Recruitment Status : Completed
First Posted : June 1, 2007
Results First Posted : December 20, 2010
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar I Depression
Interventions Drug: Armodafinil
Drug: Placebo
Enrollment 257
Recruitment Details 42 centers in the US, Romania, Bulgaria, and Hungary. First participant enrolled: June 2007/ Last participant last visit: December 2008
Pre-assignment Details The study consisted of a 1 to 2 week screening period, an 8 week double blind treatment period, and a 1 week follow up period.
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Period Title: Overall Study
Started 128 [1] 129 [2]
Completed 89 90
Not Completed 39 39
Reason Not Completed
Adverse Event             16             11
Lack of Efficacy             1             3
Lost to Follow-up             4             6
Physician Decision             3             1
Protocol Violation             10             7
Withdrawal by Subject             3             9
Miscellaneous             2             2
[1]
Two of these subjects were randomized but never received study medication.
[2]
Four of these subjects were randomized but never received study medication.
Arm/Group Title Armodafinil 150 mg/Day Placebo Total
Hide Arm/Group Description Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased. Total of all reporting groups
Overall Number of Baseline Participants 128 129 257
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 129 participants 257 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
128
 100.0%
129
 100.0%
257
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 129 participants 257 participants
42.6  (11.34) 44.9  (11.53) 43.7  (11.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 129 participants 257 participants
Female
64
  50.0%
76
  58.9%
140
  54.5%
Male
64
  50.0%
53
  41.1%
117
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants 129 participants 257 participants
United States 115 105 220
Hungary 0 2 2
Romania 5 7 12
Bulgaria 8 15 23
1.Primary Outcome
Title The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.
Time Frame Baseline and 8 weeks from start of study drug administration (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-15.6  (1.32) -12.5  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0439
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.
Time Frame Baseline and 1 week following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 120 118
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-6.5  (0.84) -4.8  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0795
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.
Time Frame Baseline and 2 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 108 112
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-10.0  (1.04) -7.3  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0272
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.
Time Frame Baseline and 3 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 102 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-13.1  (1.16) -10.7  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0802
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-13.7  (1.19) -12.1  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2407
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.
Time Frame Baseline and 6 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 92 92
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-16.7  (1.36) -13.7  (1.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0502
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30.
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-17.8  (1.41) -14.8  (1.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0612
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).
Time Frame Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Measure Type: Number
Unit of Measure: Participants
Remission 30 22
No Remission 94 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1980
Comments P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "response" (> 50% decrease from baseline in total score).
Time Frame Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Measure Type: Number
Unit of Measure: Participants
Response 46 47
No Response 78 76
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8960
Comments P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "sustained remission" (total score <= 11 that persists over the four week period from Week 4 to Week 8).
Time Frame Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Measure Type: Number
Unit of Measure: Participants
Sustained Remission 13 8
No Sustained Remission 111 115
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2575
Comments P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
11.Secondary Outcome
Title Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a "sustained response" (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8).
Time Frame Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Measure Type: Number
Unit of Measure: Participants
Sustained Response 23 17
No Sustained Response 101 106
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3129
Comments P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.
Time Frame Baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by IDS-C30 at baseline and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.6  (0.24) -1.2  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1565
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by IDS C30 at baseline and Week 4
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.2  (0.26) -1.1  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6737
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.0  (0.28) -1.6  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2249
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.
Time Frame Baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects assessed with IDS-C30 at baseline and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.4  (0.06) -0.2  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0862
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects assessed with IDS-C30 at baseline and at week 4
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.2  (0.07) -0.2  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9281
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
Hide Description The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.3  (0.08) -0.2  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4428
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.
Time Frame Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who had both a baseline observation and at least one observation after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 118 116
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-12.3  (1.10) -10.2  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0965
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 4
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-9.6  (1.03) -8.9  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5389
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 8
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-13.4  (1.20) -11.0  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0793
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).
Time Frame Baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at least one observation after baseline.
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 123
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-7.0  (0.55) -6.5  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3814
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1
Time Frame Baseline and 1 week following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 1 week
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 120 118
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.5  (0.42) -3.7  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8099
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2
Time Frame Baseline and 2 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 2 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 108 113
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.0  (0.44) -4.1  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0968
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.
Time Frame Baseline and 3 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at week 3
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 102 101
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.8  (0.52) -5.0  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1605
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 4 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-6.4  (0.53) -5.6  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1869
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.
Time Frame Baseline and 6 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 6 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 92 92
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-7.8  (0.58) -6.7  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0817
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
Hide Description The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 8 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-8.2  (0.58) -7.6  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3712
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)
Hide Description The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).
Time Frame Baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the questionnaire at baseline and at any appropriate time point after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 115 112
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.2  (1.12) 7.4  (1.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5427
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)
Hide Description The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the questionnaire at baseline and at 4 weeks.
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 95 95
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.9  (1.16) 4.6  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3463
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)
Hide Description The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed questionnaire at baseline and at 8 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 85 86
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
10.1  (1.29) 8.5  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2730
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score
Hide Description The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).
Time Frame baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the HAM-A at baseline and at least once after baseline
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 117 116
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.1  (0.60) -3.9  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7791
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
Hide Description The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the HAM-A at baseline and at 4 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.6  (0.58) -3.5  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
Hide Description The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who completed the HAM-A at baseline and at 8 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 90
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.7  (0.68) -4.4  (0.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6431
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
34.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Endpoint are presented.
Time Frame Baseline and 8 weeks (or last observation after baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects assessed by CGI-BP at Baseline and at least one observation after Baseline.
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 124 122
Measure Type: Number
Unit of Measure: Participants
Responder 64 60
Non Responder 60 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6631
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder.
35.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 1
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 1 are presented.
Time Frame Baseline and 1 week following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-BP at Baseline and Week 1
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Participants
Responder 12 12
Non Responder 107 105
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9768
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder
36.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 2
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 2 are presented.
Time Frame Baseline and 2 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-BP at baseline and week 2
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 108 110
Measure Type: Number
Unit of Measure: Participants
Responder 25 26
Non Responder 83 84
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9873
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment fro bipolar disorder
37.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 3
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 3 are presented.
Time Frame Baseline and 3 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at 3 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 102 100
Measure Type: Number
Unit of Measure: Participants
Responder 38 32
Non Responder 64 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4567
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder
38.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 4
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 4 are presented.
Time Frame Baseline and 4 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at 4 weeks
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 99 97
Measure Type: Number
Unit of Measure: Participants
Responder 46 42
Non Responder 53 55
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6475
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder
39.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 6
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 6 are presented.
Time Frame Baseline and 6 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at Week 6
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 92 92
Measure Type: Number
Unit of Measure: Participants
Responder 47 43
Non Responder 45 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5066
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder
40.Secondary Outcome
Title The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 8
Hide Description CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of "much improved" or "very much improved". The number of responders at Week 8 are presented.
Time Frame Baseline and 8 weeks following the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at week 8
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description:
Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Overall Number of Participants Analyzed 89 88
Measure Type: Number
Unit of Measure: Participants
Responder 52 47
Non Responder 37 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil 150 mg/Day, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4438
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for concurrent treatment for bipolar disorder
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 150 mg/Day Placebo
Hide Arm/Group Description Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
All-Cause Mortality
Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/126 (2.38%)      3/125 (2.40%)    
Gastrointestinal disorders     
Small intestinal obstruction *  1/126 (0.79%)  1 0/125 (0.00%)  0
Psychiatric disorders     
Depression *  1/126 (0.79%)  1 1/125 (0.80%)  1
Mania *  0/126 (0.00%)  0 2/125 (1.60%)  2
Reproductive system and breast disorders     
Epididymal cyst *  1/126 (0.79%)  1 0/125 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Armodafinil 150 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/126 (44.44%)      54/125 (43.20%)    
Gastrointestinal disorders     
Diarrhoea *  12/126 (9.52%)  8/125 (6.40%) 
Nausea *  9/126 (7.14%)  6/125 (4.80%) 
Dry Mouth *  8/126 (6.35%)  5/125 (4.00%) 
Vomiting *  5/126 (3.97%)  4/125 (3.20%) 
Toothache *  1/126 (0.79%)  5/125 (4.00%) 
General disorders     
Fatigue *  4/126 (3.17%)  1/125 (0.80%) 
Infections and infestations     
Upper respiratory tract infection *  6/126 (4.76%)  9/125 (7.20%) 
Nasopharyngitis *  2/126 (1.59%)  4/125 (3.20%) 
Investigations     
Weight increased *  1/126 (0.79%)  6/125 (4.80%) 
Nervous system disorders     
Headache *  14/126 (11.11%)  12/125 (9.60%) 
Somnolence *  6/126 (4.76%)  2/125 (1.60%) 
Tremor *  4/126 (3.17%)  3/125 (2.40%) 
Psychiatric disorders     
Insomnia *  13/126 (10.32%)  10/125 (8.00%) 
Restlessness *  7/126 (5.56%)  1/125 (0.80%) 
Anxiety *  5/126 (3.97%)  2/125 (1.60%) 
Mania *  1/126 (0.79%)  4/125 (3.20%) 
Initial insomnia *  0/126 (0.00%)  4/125 (3.20%) 
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea *  4/126 (3.17%)  1/125 (0.80%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Cephalon, Inc.
Phone: 1-800-896-5855
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00481195     History of Changes
Obsolete Identifiers: NCT00547222
Other Study ID Numbers: C10953/2032/DP/US
First Submitted: May 30, 2007
First Posted: June 1, 2007
Results First Submitted: April 30, 2010
Results First Posted: December 20, 2010
Last Update Posted: July 19, 2013