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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00057551
First received: April 4, 2003
Last updated: May 3, 2016
Last verified: May 2016

April 4, 2003
May 3, 2016
April 2003
March 2007   (final data collection date for primary outcome measure)
Remission [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits
Not Provided
Complete list of historical versions of study NCT00057551 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Research Evaluating the Value of Augmenting Medication With Psychotherapy
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
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Depressive Disorder
  • Behavioral: Brief Supportive Psychotherapy
    brief supportive psychotherapy
  • Behavioral: CBASP
    psychotherapy developed for chronic depression
    Other Name: Cognitive Behavioral Analysis System of Psychotherapy
  • Drug: Medication Only
    antidepressant medication
    Other Name: one of five antidepressants
  • Experimental: CBASP
    Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
    Intervention: Behavioral: CBASP
  • Active Comparator: Brief Supportive Psychotherapy
    Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
    Intervention: Behavioral: Brief Supportive Psychotherapy
  • Active Comparator: Medication Only
    Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
    Intervention: Drug: Medication Only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
491
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057551
U01MH062475, U01MH062475, U01MH061504, U01MH061562, U01MH061587, U01MH061590, U01MH062465, U01MH062491, U01MH062546, U01MH063481
Yes
No
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: James H Kocsis weill cornell mc
Weill Medical College of Cornell University
May 2016

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