Not Signed In -
Sertraline |
Zoloft |
Clinical Trial: Research Evaluating the Value of Augmenting Medication with Psychotherapy (REVAMP)
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to determine whether psychotherapy is an effective treatment for patients with chronic depression who have not completely responded to antidepressant medication.
| Condition | Treatment or Intervention |
|---|---|
| Depression Depressive Disorder | Behavior: Supportive Therapy Behavior: Cognitive Behavioral Analysis System of Psychotherapy Drug: Sertraline Drug: Escitalopram Drug: Bupropion SR or XL Drug: Venlafaxine XR Drug: Mirtazapine |
MedlinePlus related topics: Depression; Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: CBASP Augmentation for Treatment of Chronic Depression
Expected Total Enrollment: 909
Study start: April 2003; Expected completion: March 2006
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 - 75 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Arizona
University of Arizona, Tucson, Arizona, 85724-5002, United States; Recruiting
Alan Gelenberg, M.D., Principal Investigator
John Misiaszek, M.D., Sub-Investigator
California
Stanford University, Palo Alto, California, 94305, United States; Recruiting
Alan Schatzberg, M.D., Principal Investigator
Bruce Arnow, Ph.D, Sub-Investigator
Helena Kraemer, Ph.D, Sub-Investigator
Rachel Manber, Ph.D., Sub-Investigator
Georgia
Emory University, Atlanta, Georgia, 30329, United States; Recruiting
Philip Ninan, M.D., Principal Investigator
Steve Garlow, M.D., Ph.D., Sub-Investigator
Charles Nemeroff, M.D., Ph.D., Sub-Investigator
Barbara Rothbaum, Ph.D, Sub-Investigator
New York
Weill-Cornell Medical College Payne Whitney Clinic, New York, New York, 10021, United States; Recruiting
James H. Kocsis, M.D., Principal Investigator
John C. Markowitz, M.D., Sub-Investigator
Richard Friedman, M.D., Sub-Investigator
SUNY- Stony Brook, New York, New York, 11794, United States; Recruiting
Daniel N. Klein, Ph.D., Principal Investigator
Thomas D'Zurilla, Ph.D., Sub-Investigator
Frank Dowling, M.D., Sub-Investigator
Dina Vivian, Ph.D., Sub-Investigator
Pennsylvania
University of Pittsburgh, Pittsburgh, Pennsylvania, 15213-2600, United States; Recruiting
Michael Thase, M.D., Principal Investigator
Edward Friedman, M.D,, Sub-Investigator
Robert Howland, M.D., Sub-Investigator
Rhode Island
Brown University, Providence, Rhode Island, 02906, United States; Recruiting
Martin Keller, M.D., Principal Investigator
Gabor Keitner, M.D., Sub-Investigator
Ivan Miller, Ph.D., Sub-Investigator
Steven Bruce, Ph.D., Sub-Investigator
Texas
University of Texas Southwestern Medical Center, Dallas, Texas, 75235, United States; Recruiting
Madhukar Trivedi, M.D., Principal Investigator
A. John Rush, M.D., Sub-Investigator
David W Morris, Ph.D., Sub-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
Record last reviewed: March 2005
Last Updated: March 24, 2005
Record first received: April 4, 2003
ClinicalTrials.gov Identifier: NCT00057551
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Sertraline (Drug Digest)
- Zoloft (Drug Digest)
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