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Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00057551
First received: April 4, 2003
Last updated: May 3, 2016
Last verified: May 2016
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Depression
Depressive Disorder
Interventions: Behavioral: Brief Supportive Psychotherapy
Behavioral: CBASP
Drug: Medication Only

  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
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Reporting Groups
  Description
CBASP Cognitive Behavioral Analysis System of Psychotherapy
Brief Supportive Psychotherapy Brief Supportive Psychotherapyherapy
Medication Only

An algorithm including Sertraline, Escitalopram

Bupropion SR or XL

Venlafaxine XR

Mirtazapine


Participant Flow:   Overall Study
    CBASP     Brief Supportive Psychotherapy     Medication Only  
STARTED     200     195     96  
COMPLETED     175     168     80  
NOT COMPLETED     25     27     16  



  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
CBASP Cognitive Behavioral Analysis System of Psychotherapy
Brief Supportive P Brief Supportive Psychotherapyherapy
Medication Only

Sertraline

Escitalopram

Bupropion SR or XL

Venlafaxine XR

Mirtazapine

Total Total of all reporting groups

Baseline Measures
    CBASP     Brief Supportive P     Medication Only     Total  
Number of Participants  
[units: participants]
  200     195     96     491  
Age  
[units: years]
Mean (Standard Deviation)
  43.2  (13.4)     46.4  (11.7)     45.3  (11.9)     45.9  (11.8)  
Gender  
[units: participants]
       
Female     112     113     47     272  
Male     88     82     49     219  
Region of Enrollment  
[units: participants]
       
United States     200     195     96     491  
Hamilton Depression Scale [1]
[units: units on a scale]
Mean (Standard Deviation)
  19.52  (8.26)     19.44  (8.31)     18.4  (8.8)     19.48  (8.27)  
[1] Scores range from 0-72 with higher scores indicating more severe depression



  Outcome Measures

1.  Primary:   Remission   [ Time Frame: 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
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  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: James H. Kocsis, M.D.
Organization: Weill Cornell Medical College
phone: 212-746-5913
e-mail: jhk2002@med.cornell.edu


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

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00057551     History of Changes
Other Study ID Numbers: U01MH062475 ( US NIH Grant/Contract Award Number )
U01MH061504 ( US NIH Grant/Contract Award Number )
U01MH061562 ( US NIH Grant/Contract Award Number )
U01MH061587 ( US NIH Grant/Contract Award Number )
U01MH061590 ( US NIH Grant/Contract Award Number )
U01MH062465 ( US NIH Grant/Contract Award Number )
U01MH062491 ( US NIH Grant/Contract Award Number )
U01MH062546 ( US NIH Grant/Contract Award Number )
U01MH063481 ( US NIH Grant/Contract Award Number )
Study First Received: April 4, 2003
Results First Received: April 7, 2015
Last Updated: May 3, 2016
Health Authority: United States: Federal Government