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

November 1, 2017 updated by: Weill Medical College of Cornell University

CBASP Augmentation for Treatment of Chronic Depression

This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.

Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Study Type

Interventional

Enrollment (Actual)

491

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-5002
        • University of Arizona
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
    • New York
      • New York, New York, United States, 10021
        • Weill-Cornell Medical College Payne Whitney Clinic
      • New York, New York, United States, 11794
        • SUNY- Stony Brook
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2600
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Brown University
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Major depressive episode
  • Depressive symptoms > 2 years without remission
  • Hamilton Depression Scale (HAM-D) score > 20
  • Fluent in English

Exclusion Criteria

  • Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder
  • Serious, unstable, or terminal medical condition
  • Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
  • Previous treatment with CBASP
  • Previous ineffective treatment with 4 of the medication treatments used in the study
  • Substance abuse
  • Pregnancy
  • Not willing to end other psychiatric treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBASP
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Behavioral: CBASP
psychotherapy developed for chronic depression
Other Names:
  • Cognitive Behavioral Analysis System of Psychotherapy
Active Comparator: Brief Supportive Psychotherapy
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Behavioral: Brief Supportive Psychotherapy
brief supportive psychotherapy
Active Comparator: Medication Only
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Drug: Medication Only
antidepressant medication
Other Names:
  • one of five antidepressants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission
Time Frame: 12 weeks
Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: James H Kocsis, Weill Cornell MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 7, 2003

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH062475 (U.S. NIH Grant/Contract)
  • U01MH061504 (U.S. NIH Grant/Contract)
  • U01MH061562 (U.S. NIH Grant/Contract)
  • U01MH061587 (U.S. NIH Grant/Contract)
  • U01MH061590 (U.S. NIH Grant/Contract)
  • U01MH062465 (U.S. NIH Grant/Contract)
  • U01MH062491 (U.S. NIH Grant/Contract)
  • U01MH062546 (U.S. NIH Grant/Contract)
  • U01MH063481 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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