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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
  Purpose
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 Intervention Phase
Depression
Depressive Disorder
Behavioral: Brief Supportive Psychotherapy
Behavioral: CBASP
Drug: Medication Only
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CBASP Augmentation for Treatment of Chronic Depression

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Remission [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits


Enrollment: 491
Study Start Date: April 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057551

Locations
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)
Investigators
Principal Investigator: James H Kocsis weill cornell mc
  More Information

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  U01MH061504  U01MH061562  U01MH061587  U01MH061590  U01MH062465  U01MH062491  U01MH062546  U01MH063481 
Study First Received: April 4, 2003
Results First Received: April 7, 2015
Last Updated: May 3, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 27, 2016