Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP) - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00057551

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:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Bupropion hydrochloride Bupropion Citalopram hydrobromide Citalopram Sertraline hydrochloride Sertraline Mirtazapine Venlafaxine Venlafaxine hydrochloride Escitalopram Escitalopram oxalate

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:

Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, Trivedi MH, Zajecka J. A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med. 2000 May 18;342(20):1462-70.

Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough JP, Fawcett JA, Kornstein S, LaVange L, Harrison W. Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998 Nov 18;280(19):1665-72.

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):

Klein DN, Leon AC, Li C, D'Zurilla TJ, Black SR, Vivian D, Dowling F, Arnow BA, Manber R, Markowitz JC, Kocsis JH. Social problem solving and depressive symptoms over time: a randomized clinical trial of cognitive-behavioral analysis system of psychotherapy, brief supportive psychotherapy, and pharmacotherapy. J Consult Clin Psychol. 2011 Jun;79(3):342-52.

Kocsis JH, Gelenberg AJ, Rothbaum BO, Klein DN, Trivedi MH, Manber R, Keller MB, Leon AC, Wisniewski SR, Arnow BA, Markowitz JC, Thase ME; REVAMP Investigators. Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial. Arch Gen Psychiatry. 2009 Nov;66(11):1178-88.

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 February 13, 2012