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Completed

NCT Number: NCT00057551

Research Evaluating the Value of Augmenting Medication With Psychotherapy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Supportive Psychotherapy

Behavioral

brief supportive psychotherapy

CBASP

Behavioral

psychotherapy developed for chronic depression

Other names: Cognitive Behavioral Analysis System of Psychotherapy

Medication Only

Drug

antidepressant medication

Other names: one of five antidepressants

Primary outcomes

  1. Remission

    Time frame: 12 weeks

    Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

CBASP Augmentation for Treatment of Chronic Depression

Acronym: REVAMP

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Apr 7, 2003
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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