Research Evaluating the Value of Augmenting Medication With Psychotherapy

Phase 4

Completed

• Conditions: Depressive Disorder; Depression
• Interventions: Behavioral: CBASP; Behavioral: Brief Supportive Psychotherapy; Drug: Medication Only

• Registration Number: NCT00057551
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Results First Submitted: 2015-04-07
• Results First Submitted QC: 2016-05-03
• Results First Posted: 2016-06-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBASP	CBASP	Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Brief Supportive Psychotherapy	Brief Supportive Psychotherapy	Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)
Medication Only	Medication Only	Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine

Primary Outcome Measures

Name	Time	Method
Remission	12 weeks	Hamilton Depression Scale (HAM-D)\<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits

Trial Locations

Locations (8)

Weill-Cornell Medical College Payne Whitney Clinic; 🇺🇸 New York, New York, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

SUNY- Stony Brook; 🇺🇸 New York, New York, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States