This trial is active, not recruiting.

Conditions depression, depressive disorder
Treatments supportive therapy, cognitive behavioral analysis system of psychotherapy, sertraline, escitalopram, bupropion sr or xl, venlafaxine xr, mirtazapine
Sponsor Weill Medical College of Cornell University
Collaborator National Institute of Mental Health (NIMH)
Start date April 2003
End date March 2006
Trial size 909 participants
Trial identifier NCT00057551, DSIR 83-ATSO, U01 MH61504, U01 MH61562, U01 MH61587, U01 MH61590, U01 MH62465, U01 MH62475, U01 MH62491, U01 MH62546, U01 MH63481, U01MH062475


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title CBASP Augmentation for Treatment of 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.