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

• ClinicalTrials.gov Identifier: NCT00057551
• Recruitment Status: Completed
• First Posted: April 7, 2003
• Results First Posted: June 10, 2016
• Last Update Posted: December 6, 2017
• Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Weill Medical College of Cornell University

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
• Actual Primary Completion Date: March 2007
• Actual Study Completion Date: March 2007

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

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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. Erratum in: N Engl J Med 2001 Jul 19;345(3):232.

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

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

Shankman SA, Gorka SM, Katz AC, Klein DN, Markowitz JC, Arnow BA, Manber R, Rothbaum BO, Thase ME, Schatzberg AF, Keller MB, Trivedi MH, Kocsis JH. Side Effects to Antidepressant Treatment in Patients With Depression and Comorbid Panic Disorder. J Clin Psychiatry. 2017 Apr;78(4):433-440. doi: 10.4088/JCP.15m10370.

Shankman SA, Campbell ML, Klein DN, Leon AC, Arnow BA, Manber R, Keller MB, Markowitz JC, Rothbaum BO, Thase ME, Kocsis JH. Dysfunctional attitudes as a moderator of pharmacotherapy and psychotherapy for chronic depression. J Psychiatr Res. 2013 Jan;47(1):113-21. doi: 10.1016/j.jpsychires.2012.09.018. Epub 2012 Oct 25.

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. doi: 10.1037/a0023208.

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. doi: 10.1001/archgenpsychiatry.2009.144.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT00057551
• Other Study ID Numbers: U01MH062475 ( U.S. NIH Grant/Contract ); 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
• 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:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Antidepressive Agents; Psychotropic Drugs