Research Evaluating the Value of Augmenting Medication With Psychotherapy

Depression Clinical Trial

— REVAMP  

Official title:

CBASP Augmentation for Treatment of Chronic Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057551
• Other study ID #: U01MH062475
• Secondary ID: U01MH062475U01MH
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2003
• Last updated: November 1, 2017
• Start date: April 2003
• Est. completion date: March 2007

Study information

• Verified date: November 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Brief Supportive Psychotherapy
brief supportive psychotherapy
• CBASP
psychotherapy developed for chronic depression

Drug:
• Medication Only
antidepressant medication

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	SUNY- Stony Brook	New York	New York
United States	Weill-Cornell Medical College Payne Whitney Clinic	New York	New York
United States	Stanford University	Palo Alto	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Brown University	Providence	Rhode Island
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

J. P. McCullough, Jr. Treatment for Chronic Depression. Cognitive Behavioral Analysis System of Psychotherapy, New York: Guilford Press, 2000

Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L, Schatzberg A, Russell J, Hirschfeld R, Klein D, McCullough JP, Fawcett JA, Kornstein S, LaVange L, Harrison W. Maintenance phase efficacy of sertraline for chronic depression: a randomized controlled trial. JAMA. 1998 Nov 18;280(19):1665-72. — View Citation

Keller MB, McCullough JP, Klein DN, Arnow B, Dunner DL, Gelenberg AJ, Markowitz JC, Nemeroff CB, Russell JM, Thase ME, Trivedi MH, Zajecka J. A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression. N Engl J Med. 2000 May 18;342(20):1462-70. Erratum in: N Engl J Med 2001 Jul 19;345(3):232. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission	Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits	12 weeks