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

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status and phase

Completed
Phase 4

Conditions

Depression
Depressive Disorder

Treatments

Behavioral: Brief Supportive Psychotherapy
Behavioral: CBASP
Drug: Medication Only

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00057551
U01MH062491 (U.S. NIH Grant/Contract)
U01MH062465 (U.S. NIH Grant/Contract)
U01MH061504 (U.S. NIH Grant/Contract)
U01MH061562 (U.S. NIH Grant/Contract)
U01MH062475 (U.S. NIH Grant/Contract)
U01MH062546 (U.S. NIH Grant/Contract)
U01MH063481 (U.S. NIH Grant/Contract)
U01MH061587 (U.S. NIH Grant/Contract)
U01MH061590 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

491 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

491 participants in 3 patient groups

CBASP
Experimental group
Description:
Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Treatment:
Behavioral: CBASP
Brief Supportive Psychotherapy
Active Comparator group
Description:
Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Treatment:
Behavioral: Brief Supportive Psychotherapy
Medication Only
Active Comparator group
Description:
Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine
Treatment:
Drug: Medication Only

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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