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Abilify as an Adjunctive Treatment for Refractory Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220636
First Posted: September 22, 2005
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
Results First Submitted: April 15, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
First Submitted: September 21, 2005
First Posted: September 22, 2005
Results First Submitted: April 15, 2009
Results First Posted: February 20, 2015
Last Update Posted: May 26, 2016