Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01305408
First received: February 25, 2011
Last updated: January 15, 2015
Last verified: January 2015
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Armodafinil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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, Monaco, San Marino, and Vatican City Region 4: Rest of World

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.

Reporting Groups
  Description
Placebo Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
Armodafinil 150 mg/Day Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.

Participant Flow:   Overall Study
    Placebo     Armodafinil 150 mg/Day  
STARTED     199     200  
Safety Population     198 [1]   200 [2]
Full Analysis Population     196 [3]   197 [3]
COMPLETED     167     169  
NOT COMPLETED     32     31  
Adverse Event                 10                 7  
Lack of Efficacy                 3                 4  
Withdrawal by Subject                 9                 9  
Protocol Violation                 4                 6  
Lost to Follow-up                 5                 3  
Noncompliance with study medication                 0                 1  
Noncompliance with study procedures                 0                 1  
Not specified                 1                 0  
[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



  Baseline Characteristics
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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.
Randomized participants

Reporting Groups
  Description
Placebo Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
Armodafinil 150 mg/Day Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Armodafinil 150 mg/Day     Total  
Number of Participants  
[units: participants]
  199     200     399  
Age  
[units: years]
Mean (Standard Deviation)
  43.7  (11.62)     45.3  (11.26)     44.5  (11.45)  
Gender  
[units: participants]
     
Female     121     120     241  
Male     78     80     158  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     14     22     36  
Not Hispanic or Latino     183     176     359  
Unknown or Not Reported     2     2     4  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     2     2  
Asian     1     2     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     16     14     30  
White     176     182     358  
More than one race     0     0     0  
Unknown or Not Reported     6     0     6  
Weight  
[units: kg]
Mean (Standard Deviation)
  81.2  (17.46)     80.7  (17.54)     80.9  (17.48)  
Height  
[units: cm]
Mean (Standard Deviation)
  168.4  (9.32)     168.9  (9.23)     168.6  (9.27)  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  28.7  (5.95)     28.2  (5.52)     28.4  (5.73)  
Time Since Start of Current Depressive Episode  
[units: weeks]
Mean (Standard Deviation)
  12.1  (9.10)     12.3  (9.89)     12.2  (9.49)  
Time Since First Diagnosis for Bipolar  
[units: years]
Mean (Standard Deviation)
  9.9  (8.72)     10.7  (8.55)     10.3  (8.63)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Day 0 (baseline), Week 8 ]

2.  Secondary:   Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score   [ Time Frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

3.  Secondary:   Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

4.  Secondary:   Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)   [ Time Frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

5.  Secondary:   Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)   [ Time Frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

6.  Secondary:   Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression   [ Time Frame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

7.  Secondary:   Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale   [ Time Frame: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation ]

8.  Secondary:   Participants With Treatment-Emergent Adverse Events (TEAE)   [ Time Frame: Day 1 to Week 9 ]

9.  Secondary:   Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score   [ Time Frame: Day 0 (baseline), last postbaseline observation ]

10.  Secondary:   Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score   [ Time Frame: Day 0 (baseline), last postbaseline observation ]

11.  Secondary:   Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score   [ Time Frame: Day 0 (baseline), last postbaseline observation ]

12.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

13.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

14.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

15.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

16.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

17.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

18.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

19.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

20.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

21.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

22.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]

23.  Secondary:   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   [ Time Frame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com


No publications provided


Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01305408     History of Changes
Other Study ID Numbers: C10953/3073, 2010-023623-26
Study First Received: February 25, 2011
Results First Received: January 15, 2015
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration