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Trial record 72 of 2811 for:    Rating | "Depressive Disorder"

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy

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ClinicalTrials.gov Identifier: NCT00683852
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Aripiprazole 5mg
Drug: Aripiprazole 2mg
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
23 U.S. sites enrolled 225 patients over 10 months. 221 patients are included in the analysis. Enrollment began in September, 2008 and completed in July, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients completed a SAFER interview before randomization. No other significant events occurred prior to randomization.

Reporting Groups
  Description
ADAPT Drug/Drug Group Patients randomly assigned to the drug/drug sequence: the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
ADAPT Placebo/Placebo Group Patients randomly assigned to the placebo/placebo sequence: the patients will receive a placebo treatment during the first phase of the study, and a placebo treatment in the second phase.
ADAPT Placebo/Drug Group Patients will be randomly assigned to placebo during the first phase of the study. In the second phase of the study, they will receive the aripiprazole drug at a dose of 2 mg/day.

Participant Flow for 2 periods

Period 1:   30-Day Phase 1 Period
    ADAPT Drug/Drug Group   ADAPT Placebo/Placebo Group   ADAPT Placebo/Drug Group
STARTED   56   84   85 
COMPLETED   54   83   84 
NOT COMPLETED   2   1   1 

Period 2:   30-Day Phase 2 Period
    ADAPT Drug/Drug Group   ADAPT Placebo/Placebo Group   ADAPT Placebo/Drug Group
STARTED   54   83   84 
COMPLETED   48   78   75 
NOT COMPLETED   6   5   9 



  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.
This data was analyzed for the study by comparing placebo vs. drug. Therefore the two groups (placebo/placebo and placebo/drug) that started with placebo during the first phase of the study are combined as one group called Placebo. The patients who were took the study drug in both phases are in the Drug/Drug group.

Reporting Groups
  Description
ADAPT Drug/Drug Group patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase.
ADAPT Placebo Group (Placebo/Placebo & Placebo/Drug Groups) This data was analyzed for the study by comparing placebo vs. drug. Therefore the two groups (placebo/placebo and placebo/drug) that started with placebo during the first phase of the study are combined as one group. Patients in the placebo/placebo sequence received a placebo treatment during the first phase of the study, and a placebo treatment in the second phase. Patients in the placebo/drug sequence received a placebo treatment during the first phase of the study and they received the aripiprazole drug at a dose of 2 mg/day in the second phase of the study.
Total Total of all reporting groups

Baseline Measures
   ADAPT Drug/Drug Group   ADAPT Placebo Group (Placebo/Placebo & Placebo/Drug Groups)   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   169   225 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      56 100.0%      169 100.0%      225 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.36  (10.35)   45.06  (11.34)   45.16  (10.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  66.1%      108  63.9%      145  64.4% 
Male      19  33.9%      61  36.1%      80  35.6% 
Region of Enrollment 
[Units: Participants]
     
United States   56   169   225 


  Outcome Measures

1.  Primary:   MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate   [ Time Frame: 12 weeks ]

2.  Secondary:   MADRS (Montgomery-Asberg Depression Rating Scale) Readmission Rate   [ Time Frame: 12 weeks ]

3.  Secondary:   Mean Change in MADRS (Montgomery-Asberg Depression Rating Scale) Score From Baseline to the End of Follow-up   [ Time Frame: Baseline and 12 Weeks ]

4.  Secondary:   Mean Change in Clinical Global Impression of Severity (CGI-S)   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Mean Change in Symptom Questionnaire (SQ)   [ Time Frame: Baseline and 12 weeks ]

6.  Other Pre-specified:   Treatment Emergent AEs in Two Treatment Groups - Safety Sample   [ Time Frame: 12 Weeks ]

7.  Other Pre-specified:   Number of Patients With Treatment Emergent AEs in Two Treatment Groups - Placebo Non-Responders   [ Time Frame: 12 Weeks ]

8.  Other Pre-specified:   Number of Patients With Treatment Emergent AEs in Two Treatment Groups - People Exclusively on Drug or Placebo Throughout the Study   [ Time Frame: 12 Weeks ]


  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 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.
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: Martina Flynn, Director, Clinical Trial Operations
Organization: Massachusetts General Hospital, CTNI
phone: 617-643-6028
e-mail: mflynn2@partners.org


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

Responsible Party: Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00683852     History of Changes
Other Study ID Numbers: BMS - 2008A053242
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: November 12, 2012
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017