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Trial record 31 of 239 for:    (armodafinil)

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT01072630
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : January 26, 2015
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Armodafinil
Drug: Placebo
Enrollment 492
Recruitment Details Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Malta, Monaco, San Marino, and Vatican City Region 4: Rest of World
Pre-assignment Details Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. The 200-mg/day armodafinil treatment group was discontinued per protocol Amendment 03. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Period Title: Overall Study
Started 230 232 30
Safety Population 229 [1] 231 [1] 30 [2]
Full Analysis Population 224 [3] 230 [3] 28 [3]
Completed 175 172 17
Not Completed 55 60 13
Reason Not Completed
Adverse Event             11             19             2
Lack of Efficacy             10             10             1
Withdrawal by Subject             8             7             2
Protocol Violation             10             8             4
Lost to Follow-up             11             11             1
Noncompliance with study medication             1             1             1
Noncompliance with study procedures             1             2             1
Not specified             3             2             1
[1]
Treated participants. One participant was randomized but not treated.
[2]
Treated participants.
[3]
Treated participants who have at least 1 postbaseline IDS-C30 efficacy assessment
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day Total
Hide Arm/Group Description Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. Total of all reporting groups
Overall Number of Baseline Participants 230 232 30 492
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 232 participants 30 participants 492 participants
43.8  (10.52) 44.4  (11.00) 41.2  (12.60) 43.9  (10.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 30 participants 492 participants
Female
125
  54.3%
128
  55.2%
20
  66.7%
273
  55.5%
Male
105
  45.7%
104
  44.8%
10
  33.3%
219
  44.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 30 participants 492 participants
Hispanic or Latino
18
   7.8%
16
   6.9%
2
   6.7%
36
   7.3%
Not Hispanic or Latino
203
  88.3%
206
  88.8%
28
  93.3%
437
  88.8%
Unknown or Not Reported
9
   3.9%
10
   4.3%
0
   0.0%
19
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 232 participants 30 participants 492 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
3
   1.3%
2
   0.9%
2
   6.7%
7
   1.4%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
54
  23.5%
49
  21.1%
13
  43.3%
116
  23.6%
White
162
  70.4%
166
  71.6%
14
  46.7%
342
  69.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
   3.9%
15
   6.5%
1
   3.3%
25
   5.1%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 230 participants 232 participants 30 participants 492 participants
86.7  (20.21) 86.3  (19.21) 96.7  (21.91) 87.1  (19.96)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 230 participants 232 participants 30 participants 492 participants
169.6  (9.88) 169.9  (9.44) 170.4  (8.25) 169.7  (9.57)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 230 participants 232 participants 30 participants 492 participants
30.2  (6.86) 29.9  (6.39) 33.6  (7.58) 30.3  (6.73)
Time Since Start of Current Depressive Episode  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 230 participants 232 participants 30 participants 492 participants
11.2  (7.79) 12.4  (8.99) 14.7  (8.73) 12.0  (8.46)
Time Since First Diagnosis for Bipolar  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 232 participants 30 participants 492 participants
11.4  (9.57) 11.7  (9.49) 13.3  (10.96) 11.6  (9.62)
1.Primary Outcome
Title Change From Baseline to Week 8 in the Total Score From 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 participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.

Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

Time Frame Day 0 (baseline), Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.
Arm/Group Title Placebo Armodafinil 150 mg/Day All Armodafinil
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
Overall Number of Participants Analyzed 224 230 258
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-18.8  (1.02) -20.9  (1.02) -20.7  (0.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Armodafinil 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1302
Comments All statistical tests were 2-tailed at the 0.05 level of significance.
Method mixed-model repeated measures (MMRM)
Comments Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.67 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, All Armodafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1350
Comments All statistical tests were 2-tailed at the 0.05 level of significance.
Method mixed-model repeated measures (MMRM)
Comments Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-4.51 to 0.61
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Hide Description

A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.

Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.

Time Frame Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (218, 223, 27) 5 7 22
Week 2 (209, 212, 25) 16 17 20
Week 4 (193, 190, 22) 28 27 41
Week 6 (182, 181, 18) 36 41 56
Week 7 (172, 178, 14) 40 44 57
Week 8 (172, 169, 17) 47 49 59
Endpoint (224, 230, 28) 39 40 39
3.Secondary Outcome
Title Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Hide Description

A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.

The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.

Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.

Time Frame Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (218, 223, 27) .5 1 7
Week 2 (209, 212, 25) 7 4 12
Week 4 (193, 190, 22) 11 8 18
Week 6 (182, 181, 18) 19 15 39
Week 7 (172, 178, 14) 19 17 43
Week 8 (172, 169, 17) 22 23 47
Endpoint (224, 230, 28) 17 18 29
4.Secondary Outcome
Title Change From Baseline to Different Treatment Weeks in the Total Score From 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 participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.

Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

Time Frame Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (218, 223, 27) -6.6  (7.59) -7.2  (8.28) -9.9  (12.92)
Week 2 (209, 212, 25) -11.1  (10.72) -11.8  (9.85) -13.9  (11.99)
Week 4 (193, 190, 22) -15.1  (12.14) -16.7  (10.98) -17.8  (12.82)
Week 6 (182, 181, 18) -18.1  (12.60) -19.1  (11.77) -20.7  (12.30)
Week 7 (172, 178, 14) -19.0  (13.38) 021.0  (12.12) -22.8  (14.57)
Week 8 (172, 169, 17) -20.2  (13.81) -22.4  (12.63) -21.8  (13.42)
Endpoint (224, 230, 28) -17.5  (14.28) -19.1  (13.55) -18.6  (13.76)
5.Secondary Outcome
Title Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Hide Description The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Time Frame Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (218, 223, 27) -2.7  (3.05) -2.9  (3.51) -4.5  (5.16)
Week 2 (209, 212, 25) -4.2  (4.02) -4.5  (3.97) -6.0  (4.63)
Week 4 (193, 190, 22) -5.7  (4.68) -6.5  (4.29) -7.4  (4.80)
Week 6 (182, 181, 18) -6.8  (4.87) -7.5  (4.58) -8.8  (5.05)
Week 7 (172, 178, 14) -7.2  (5.13) -8.1  (4.68) -9.6  (5.50)
Week 8 (172, 169, 17) -7.7  (5.42) -8.6  (4.88) -9.8  (5.68)
Endpoint (224, 230, 28) -6.7  (5.51) -7.4  (5.24) -8.1  (5.47)
6.Secondary Outcome
Title Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Hide Description The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Time Frame Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (218, 223, 27) -0.2  (0.48) -0.3  (0.58) -0.6  (0.97)
Week 2 (209, 212, 25) -0.6  (0.83) -0.6  (0.74) -0.8  (1.00)
Week 4 (193, 190, 22) -0.9  (0.99) -0.9  (0.90) -1.1  (1.02)
Week 6 (182, 181, 18) -1.1  (1.14) -1.1  (1.04) -1.3  (0.97)
Week 7 (172, 178, 14) -1.3  (1.14) -1.3  (1.08) -1.4  (1.22)
Week 8 (174, 171, 17) -1.4  (1.24) -1.5  (1.13) -1.8  (1.15)
Endpoint (224, 230, 28) -1.2  (1.27) -1.2  (1.19) -1.3  (1.21)
7.Secondary Outcome
Title Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Hide Description The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Time Frame Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 224 230 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 (193, 190, 22) 6.4  (8.74) 7.2  (10.63) 10.0  (9.74)
Week 8 (172, 171, 17) 10.8  (11.01) 11.6  (11.22) 13.4  (11.14)
Endpoint (213, 219, 25) 9.6  (11.44) 9.3  (11.85) 10.5  (10.60)
8.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAE)
Hide Description

AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.

Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.

Time Frame Day 1 to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 299 123 21
Measure Type: Number
Unit of Measure: participants
>=1 adverse event 102 123 21
Severe adverse event 7 7 1
Treatment-related adverse event 59 78 16
Deaths 0 1 0
Other serious adverse events 1 5 2
Withdrawn from study due to adverse events 11 19 2
Protocol-defined adverse events 5 3 3
9.Secondary Outcome
Title Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score
Hide Description The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Time Frame Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 226 230 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (2.76) -0.5  (3.47) -0.5  (2.71)
10.Secondary Outcome
Title Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
Hide Description HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Time Frame Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 218 221 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.3  (4.95) -4.0  (5.50) -2.6  (5.67)
11.Secondary Outcome
Title Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
Hide Description The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
Time Frame Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 217 219 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (6.89) -6.7  (7.18) -6.2  (6.93)
12.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Hide Description The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
13.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
14.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 1 0 0
15.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
16.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
17.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.

.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
18.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 0 0
Week 2 (209, 212, 25) 0 0 0
Week 4 (193, 190, 22) 0 0 0
Week 6 (182, 181, 18) 0 0 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 0 0
Endpoint (226, 230, 28) 0 0 0
19.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 10 11 2
Week 2 (209, 212, 25) 7 11 0
Week 4 (193, 190, 22) 4 9 0
Week 6 (182, 181, 18) 6 6 0
Week 7 (172, 178, 14) 3 3 0
Week 8 (174, 171, 17) 3 5 1
Endpoint (226, 230, 28) 7 10 2
20.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (218, 223, 27) 0 2 1
Week 2 (209, 212, 25) 0 1 0
Week 4 (193, 190, 22) 1 1 0
Week 6 (182, 181, 18) 0 3 0
Week 7 (172, 178, 14) 0 0 0
Week 8 (174, 171, 17) 0 1 0
Endpoint (226, 230, 28) 2 2 1
21.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (9, 10, 1) 0 0 0
Week 2 (6, 10, 0) 0 1 0
Week 4 (4, 8, 0) 0 1 0
Week 6 (5, 7, 0) 0 2 0
Week 7 (3, 3, 0) 0 0 0
Week 8 (2, 5, 0) 0 0 0
Endpoint (18, 21, 1) 1 2 0
22.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (9, 10, 1) 0 0 0
Week 2 (6, 10, 0) 0 0 0
Week 4 (4, 8, 0) 0 0 0
Week 6 (5, 7, 0) 0 0 0
Week 7 (3, 3, 0) 0 0 0
Week 8 (2, 5, 0) 0 0 0
Endpoint (18, 21, 1) 1 0 0
23.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Hide Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.

The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.

Time Frame Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
Arm/Group Title Placebo Armodafinil 150 mg/Day Armodafinil 200 mg/Day
Hide Arm/Group Description:
Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Overall Number of Participants Analyzed 229 231 30
Measure Type: Number
Unit of Measure: participants
Week 1 (9, 10, 1) 0 0 0
Week 2 (6, 10, 0) 0 0 0
Week 4 (4, 8, 0) 0 0 0
Week 6 (5, 7, 0) 0 0 0
Week 7 (3, 3, 0) 0 0 0
Week 8 (2, 5, 0) 0 0 0
Endpoint (18, 21, 1) 0 0 0
Time Frame Day 1 to Week 9
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil 150 mg/Day Armodafinil 200 mg/Day Placebo
Hide Arm/Group Description Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
All-Cause Mortality
Armodafinil 150 mg/Day Armodafinil 200 mg/Day Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil 150 mg/Day Armodafinil 200 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/231 (2.16%)      2/30 (6.67%)      1/229 (0.44%)    
Cardiac disorders       
Coronary artery disease  1  1/231 (0.43%)  1 0/30 (0.00%)  0 0/229 (0.00%)  0
General disorders       
Non-cardiac chest pain  1  1/231 (0.43%)  1 0/30 (0.00%)  0 0/229 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose  1  1/231 (0.43%)  1 0/30 (0.00%)  0 0/229 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/231 (0.00%)  0 1/30 (3.33%)  1 0/229 (0.00%)  0
Psychiatric disorders       
Mania  1  2/231 (0.87%)  2 0/30 (0.00%)  0 0/229 (0.00%)  0
Psychotic disorder  1  0/231 (0.00%)  0 1/30 (3.33%)  1 0/229 (0.00%)  0
Suicidal ideation  1  0/231 (0.00%)  0 1/30 (3.33%)  1 1/229 (0.44%)  1
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/231 (0.43%)  1 0/30 (0.00%)  0 0/229 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil 150 mg/Day Armodafinil 200 mg/Day Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/231 (34.63%)      18/30 (60.00%)      59/229 (25.76%)    
Gastrointestinal disorders       
Diarrhoea  1  11/231 (4.76%)  11 5/30 (16.67%)  8 13/229 (5.68%)  16
Dry mouth  1  10/231 (4.33%)  10 5/30 (16.67%)  6 3/229 (1.31%)  3
Dyspepsia  1  0/231 (0.00%)  0 2/30 (6.67%)  2 0/229 (0.00%)  0
Nausea  1  17/231 (7.36%)  18 4/30 (13.33%)  5 5/229 (2.18%)  5
Toothache  1  2/231 (0.87%)  2 2/30 (6.67%)  3 0/229 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  7/231 (3.03%)  7 2/30 (6.67%)  2 4/229 (1.75%)  4
Nervous system disorders       
Dizziness  1  7/231 (3.03%)  9 3/30 (10.00%)  3 2/229 (0.87%)  2
Headache  1  38/231 (16.45%)  45 4/30 (13.33%)  5 30/229 (13.10%)  39
Psychiatric disorders       
Anxiety  1  6/231 (2.60%)  6 2/30 (6.67%)  2 6/229 (2.62%)  6
Insomnia  1  12/231 (5.19%)  12 4/30 (13.33%)  5 8/229 (3.49%)  8
Suicidal ideation  1  1/231 (0.43%)  1 3/30 (10.00%)  3 2/229 (0.87%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/231 (0.00%)  0 3/30 (10.00%)  4 2/229 (0.87%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01072630     History of Changes
Other Study ID Numbers: C10953/3072
2009-016634-27 ( EudraCT Number )
First Submitted: February 19, 2010
First Posted: February 22, 2010
Results First Submitted: January 15, 2015
Results First Posted: January 26, 2015
Last Update Posted: April 27, 2016