Abilify as an Adjunctive Treatment for Refractory Depression

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00220636
First received: September 21, 2005
Last updated: February 18, 2015
Last verified: October 2014
Results First Received: April 15, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Intervention: Drug: Aripiprazole

  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
No text entered.

Reporting Groups
  Description
Aripiprazole aripiprazole augmentation treatment

Participant Flow:   Overall Study
    Aripiprazole  
STARTED     15  
COMPLETED     11  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  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 aripiprazole augmentation treatment

Baseline Measures
    Aripiprazole  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     1  
Age  
[units: years]
Mean (Standard Deviation)
  46  (13)  
Gender  
[units: participants]
 
Female     10  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
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1.  Primary:   Hamilton Depression Rating Scale (HDRS)   [ Time Frame: 12 weeks ]

2.  Secondary:   Clinical Global Impressions Improvement Scale (CGI)   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in Global Assessment of Functioning Scale (GAFS)   [ Time Frame: baseline and 12 weeks ]

4.  Secondary:   Change in Beck Depression Inventory (BDI) Score   [ Time Frame: baseline and 12 weeks ]


  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
Open label study without comparison group.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Hellerstein MD
Organization: NY State Psychiatric Institute
phone: 6467748000
e-mail: hellers@nyspi.columbia.edu


Publications:

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220636     History of Changes
Other Study ID Numbers: SLR-04-028
Study First Received: September 21, 2005
Results First Received: April 15, 2009
Last Updated: February 18, 2015
Health Authority: United States: Institutional Review Board