Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Prabha Sunderajan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00608543
First received: January 23, 2008
Last updated: October 24, 2012
Last verified: March 2012
Results First Received: November 15, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
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
Open-label Aripiprazole Augmentation Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks

Participant Flow:   Overall Study
    Open-label Aripiprazole Augmentation  
STARTED     17  
COMPLETED     13  
NOT COMPLETED     4  
Adverse Event                 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.
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Reporting Groups
  Description
Open-label Aripiprazole Augmentation Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks

Baseline Measures
    Open-label Aripiprazole Augmentation  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.18  ± 7.95  
Gender  
[units: participants]
 
Female     13  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures
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1.  Primary:   Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems   [ Time Frame: baseline and 6 weeks ]

2.  Primary:   Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems   [ Time Frame: baseline and 6 weeks ]

3.  Primary:   Spatial Working Memory (SWM) Between Errors for 6-move Problems   [ Time Frame: baseline and 6 weeks ]

4.  Primary:   Spatial Working Memory (SWM) Strategy Score   [ Time Frame: baseline and 6 weeks ]

5.  Secondary:   Quality of Life Enjoyment and Satisfaction Questionnaire   [ Time Frame: 6 weeks ]

6.  Secondary:   Change in Hamilton Rating Scale for Depression (HRSD - 17-item)   [ Time Frame: 6 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
Note that because this is an augmentation trial, reported AEs are due to combined treatment with escitalopram, citalopram, or sertraline AND aripiprazole.


  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: Dr.Prabha Sunderajan
Organization: UT Southwestern Medical Center
phone: 214-648-0156
e-mail: prabha.sunderajan@utsouthwestern.edu


No publications provided


Responsible Party: Prabha Sunderajan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00608543     History of Changes
Other Study ID Numbers: 042004-011
Study First Received: January 23, 2008
Results First Received: November 15, 2011
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board