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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00057551
First received: April 4, 2003
Last updated: June 16, 2006
Last verified: June 2006
History of Changes
  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
Depression
Depressive Disorder
 Behavioral: Supportive Therapy
Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
Drug: Sertraline
Drug: Escitalopram
Drug: Bupropion SR or XL
Drug: Venlafaxine XR
Drug: Mirtazapine

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:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 909
Study Start Date: April 2003
Estimated Study Completion Date: March 2006
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Major depressive episode
  • Depressive symptoms > 2 years without remission
  • 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 antisocical, 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
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
National Institute of Mental Health (NIMH)
Investigators
Investigator: James P. McCullough, Ph.D. Virginia Commonwealth University
  More Information

Publications:
J. P. McCullough, Jr. Treatment for Chronic Depression. Cognitive Behavioral Analysis System of Psychotherapy, New York: Guilford Press, 2000

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

ClinicalTrials.gov Identifier: NCT00057551     History of Changes
Other Study ID Numbers: U01 MH62475, DSIR 83-ATSO, U01 MH61504, U01 MH61562, U01 MH61587, U01 MH61590, U01 MH62465, U01 MH62491, U01 MH62546, U01 MH63481
Study First Received: April 4, 2003
Last Updated: June 16, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Mirtazapine
Sertraline
Venlafaxine
Bupropion
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013