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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00057551
First received: April 4, 2003
Last updated: November 1, 2013
Last verified: November 2013

April 4, 2003
November 1, 2013
April 2003
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Complete list of historical versions of study NCT00057551 on ClinicalTrials.gov Archive Site
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Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP)
CBASP Augmentation for Treatment of Chronic Depression

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
909
March 2006
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057551
U01 MH62475, U01MH062475, DSIR 83-ATSO, U01 MH61504, U01 MH61562, U01 MH61587, U01 MH61590, U01 MH62465, U01 MH62491, U01 MH62546, U01 MH63481
Not Provided
Not Provided
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigator: James P. McCullough, Ph.D. Virginia Commonwealth University
Weill Medical College of Cornell University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP