Clinical Trial: Preventing the Recurrence of Depression with Drugs and Psychotherapy

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)


The purpose of this study is to determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Condition Treatment or Intervention Phase
 Behavior: Cognitive Therapy
 Drug: Antidepressant medications
Phase IV

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Prevention of Recurrence in Depression with Drugs and CT

Further Study Details: 

Expected Total Enrollment:  450

Study start: October 2002

It is commonly believed that the combination of ADM and psychotherapy is more effective in treating depression than either treatment alone. Data indicate that CT enhances the initial effects of ADM, but little research has been conducted to determine whether prior exposure to CT prevents the onset of new depressive episodes. This study will determine the effectiveness of adding CT to ADM for the treatment of depression.

Participants are randomly assigned to receive either ADM alone or ADM plus CT for up to 18 months. Remitted patients are continued on medication for up to another 18 months until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue cognitive therapy; all recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both


Inclusion Criteria:

  • Recurrent or chronic major depressive disorder

Location and Contact Information

Steven D. Hollon, PhD      615-343-4827

      Rush Medical Center - Treatment Research Unit, Chicago,  Illinois,  60612,  United States; Recruiting
Jan A. Fawcett, MD  312-942-5372 
John Zajecka, MD  312-942-5592  Ext. 116 

      Depression Research Unit, University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Robert J. DeRubeis, PhD  215-573-5804 
Bernadette Kooi, MA  215-573-5803 

      Vanderbilt Adult Outpatient Psychiatry, Nashville,  Tennessee,  37203,  United States; Recruiting
Steven D. Hollon, PhD  615-343-4827 
Margaret Lovett, MEd  615-343-9667 

Study chairs or principal investigators

Steven D. Hollon, PhD,  Principal Investigator,  Vanderbilt University   
Robert J. DeRubeis, PhD,  Principal Investigator,  University of Pennsylvania   
Jan A. Fawcett, MD,  Principal Investigator,  Rush Medical Center   

More Information

Study ID Numbers:  60713-01A2
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  April 4, 2003 Identifier:  NCT00057577
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005