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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
42 centers in the US, Romania, Bulgaria, and Hungary. First participant enrolled: June 2007/ Last participant last visit: December 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Armodafinil 150 mg/Day 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 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.

Participant Flow:   Overall Study
    Armodafinil 150 mg/Day   Placebo
STARTED   128 [1]   129 [2] 
COMPLETED   89   90 
NOT COMPLETED   39   39 
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.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Armodafinil 150 mg/Day 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 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 Total of all reporting groups

Baseline Measures
   Armodafinil 150 mg/Day   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   129   257 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   128   129   257 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.6  (11.34)   44.9  (11.53)   43.7  (11.47) 
Gender 
[Units: Participants]
     
Female   64   76   140 
Male   64   53   117 
Region of Enrollment 
[Units: Participants]
     
United States   115   105   220 
Hungary   0   2   2 
Romania   5   7   12 
Bulgaria   8   15   23 


  Outcome Measures

1.  Primary:   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)   [ Time Frame: Baseline and 8 weeks from start of study drug administration (or last observation after baseline) ]

2.  Secondary:   The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 1 week following the start of study drug administration ]

3.  Secondary:   The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]

4.  Secondary:   The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]

5.  Secondary:   The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

6.  Secondary:   The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]

7.  Secondary:   The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

8.  Secondary:   Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]

9.  Secondary:   Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]

10.  Secondary:   Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]

11.  Secondary:   Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline) ]

12.  Secondary:   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   [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]

13.  Secondary:   Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

14.  Secondary:   Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

15.  Secondary:   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   [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]

16.  Secondary:   Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

17.  Secondary:   Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

18.  Secondary:   Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline) ]

19.  Secondary:   Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

20.  Secondary:   Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

21.  Secondary:   Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]

22.  Secondary:   Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 1 week following the start of study drug administration ]

23.  Secondary:   Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]

24.  Secondary:   Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]

25.  Secondary:   Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

26.  Secondary:   Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]

27.  Secondary:   Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

28.  Secondary:   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)   [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]

29.  Secondary:   Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

30.  Secondary:   Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

31.  Secondary:   Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score   [ Time Frame: baseline and 8 weeks (or last observation after baseline) ]

32.  Secondary:   Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

33.  Secondary:   Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]

34.  Secondary:   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)   [ Time Frame: Baseline and 8 weeks (or last observation after baseline) ]

35.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 1   [ Time Frame: Baseline and 1 week following the start of study drug administration ]

36.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 2   [ Time Frame: Baseline and 2 weeks following the start of study drug administration ]

37.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 3   [ Time Frame: Baseline and 3 weeks following the start of study drug administration ]

38.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 4   [ Time Frame: Baseline and 4 weeks following the start of study drug administration ]

39.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 6   [ Time Frame: Baseline and 6 weeks following the start of study drug administration ]

40.  Secondary:   The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 8   [ Time Frame: Baseline and 8 weeks following the start of study drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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