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



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

For Condition: Depression,Depressive Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 909

Location and Contact Information:

Overall Study Official:
JamesMcCullough,  ,  Virginia Commonwealth University

University of Arizona *Recruiting*
Tucson,  Arizona,  85724-5002
United States
Recruiting E.  Shaw 520-626-7738

Stanford University *Recruiting*
Palo Alto,  California,  94305
United States
Recruiting Jennifer  Howden 650-498-6128

Brown University *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting Steven  Bruce 401-444-1964

Emory University *Recruiting*
Atlanta,  Georgia,  30329
United States
Recruiting M.  Aull 404-712-6663

Weill-Cornell Medical College Payne Whitney Clinic *Recruiting*
New York City,  New York,  10021
United States
Recruiting James  Kocsis 212-746-5705

SUNY- Stony Brook *Recruiting*
New York City,  New York,  11794
United States
Recruiting Laura  Klein 631-632-6381

University of Texas Southwestern Medical Center *Recruiting*
Dallas,  Texas,  75235
United States
Recruiting David  Morris 214-648-0162

University of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15213-2600
United States
Recruiting Crystal  Spotts 412-246-6111


Additional Information:
Study ID Numbers:
  U01-62475-01A2;  62491,61562,61590,61504,62546,61587,63481,62465
Study Start Date: April 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057551

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