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...
Date First Received: April 4, 2003
Last Updated: June 16, 2006
Verified by: National Institute of Mental Health (NIMH), June 2006
Clinical Trial Phase: N/A | Start Date: April 2003
Overall Status: Active, not recruiting
Estimated Enrollment: 909
Brief Summary
Official Title: “CBASP Augmentation for Treatment of Chronic Depression”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Behavioral: Supportive Therapy
- Behavioral: Cognitive Behavioral Analysis System of Psychotherapy
- Drug: Sertraline
- Drug: Escitalopram
- Drug: Bupropion SR or XL
- Drug: Venlafaxine XR
- Drug: Mirtazapine
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Mental Health (NIMH)
Overall Clinical Trial Officials and Contacts
James P. McCullough, Ph.D. Virginia Commonwealth University
Related Publications
References
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.
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.
J. P. McCullough, Jr. Treatment for Chronic Depression. Cognitive Behavioral Analysis System of Psychotherapy, New York: Guilford Press, 2000
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00057551
Study ID Number: U01 MH62475
ClinicalTrials.gov Identifier: NCT00057551
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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