A Study of Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00105196
First received: March 9, 2005
Last updated: November 7, 2013
Last verified: April 2011
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: Major Depressive Disorder
Interventions: Drug: Aripiprazole+ ADT
Drug: Placebo+ ADT

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After initial screening period (7-28 days), subjects enrolled into an 8-wk prospective treatment phase (single-blind placebo plus an investigator-assigned, open-label, marketed antidepressant therapy [ADT]). Patients who met criteria for incomplete response at the end of this phase were randomized into the 6-wk double-blind phase in a 1:1 ratio.

Reporting Groups
  Description
Aripiprazole + ADT Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
Placebo + ADT Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Participant Flow:   Overall Study
    Aripiprazole + ADT     Placebo + ADT  
STARTED     177     172  
COMPLETED     147     149  
NOT COMPLETED     30     23  
Lack of Efficacy                 2                 3  
Adverse Event                 11                 3  
Withdrawal by Subject                 6                 6  
Lost to Follow-up                 3                 2  
Poor/noncompliance                 3                 4  
Protocol Violation                 5                 2  
pending surgery                 0                 1  
marijuana use                 0                 1  
Subject became unblinded                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Aripiprazole + ADT Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
Placebo + ADT Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
Total Total of all reporting groups

Baseline Measures
    Aripiprazole + ADT     Placebo + ADT     Total  
Number of Participants  
[units: participants]
  177     172     349  
Age  
[units: years]
Mean ± Standard Deviation
  45.1  ± 10.6     45.6  ± 11.3     45.4  ± 10.9  
Gender  
[units: participants]
     
Female     138     117     255  
Male     39     55     94  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     6     12  
Not Hispanic or Latino     168     162     330  
Unknown or Not Reported     3     4     7  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     3     2     5  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     14     18     32  
White     155     149     304  
Unknown or Not Reported     4     2     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline (Week 8) and Week 14 ]

2.  Secondary:   Mean Change in Sheehan Disability Scale (SDS) Mean Score   [ Time Frame: Baseline (Week 8) and Week 14 ]

3.  Secondary:   Mean Change in SDS Item Score (Social Life)   [ Time Frame: Baseline (Week 8) and Week 14 ]

4.  Secondary:   Mean Change in SDS Item Score (Family Life)   [ Time Frame: Baseline (Week 8) and Week 14 ]

5.  Secondary:   Mean Change in SDS Item Score (Work/School)   [ Time Frame: Baseline (Week 8) and Week 14 ]

6.  Other Pre-specified:   MADRS Response   [ Time Frame: Baseline (Week 8) and Week 14 ]

7.  Other Pre-specified:   Clinical Global Impression (CGI)-Improvement Response   [ Time Frame: Baseline (Week 8) and Week 14 ]

8.  Other Pre-specified:   MADRS Remission   [ Time Frame: Baseline (Week 8) and Week 14 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications:

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00105196     History of Changes
Other Study ID Numbers: CN138-165
Study First Received: March 9, 2005
Results First Received: March 27, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration