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

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ClinicalTrials.gov Identifier: NCT00057551
Recruitment Status : Completed
First Posted : April 7, 2003
Results First Posted : June 10, 2016
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Behavioral: Brief Supportive Psychotherapy Behavioral: CBASP Drug: Medication Only Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBASP Augmentation for Treatment of Chronic Depression
Study Start Date : April 2003
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: one of five antidepressants

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057551

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724-5002
United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, New York
Weill-Cornell Medical College Payne Whitney Clinic
New York, New York, United States, 10021
SUNY- Stony Brook
New York, New York, United States, 11794
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2600
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02906
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: James H Kocsis weill cornell mc
More Information

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 ( 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 )
First Posted: April 7, 2003    Key Record Dates
Results First Posted: June 10, 2016
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs