- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057551
Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP)
CBASP Augmentation for Treatment of Chronic Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724-5002
- University of Arizona
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California
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Palo Alto, California, United States, 94305
- Stanford University
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University
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New York
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New York, New York, United States, 10021
- Weill-Cornell Medical College Payne Whitney Clinic
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New York, New York, United States, 11794
- SUNY- Stony Brook
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213-2600
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Brown University
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Texas
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Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBASP
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
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psychotherapy developed for chronic depression
Other Names:
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Active Comparator: Brief Supportive Psychotherapy
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
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brief supportive psychotherapy
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Active Comparator: Medication Only
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
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antidepressant medication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission
Time Frame: 12 weeks
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Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
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12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James H Kocsis, Weill Cornell MC
Publications and helpful links
General 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. doi: 10.1056/NEJM200005183422001. 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. doi: 10.1001/jama.280.19.1665.
- J. P. McCullough, Jr. Treatment for Chronic Depression. Cognitive Behavioral Analysis System of Psychotherapy, New York: Guilford Press, 2000
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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