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
Depression	Behavior: Cognitive Therapy  Drug: Antidepressant medications	Phase IV

Further Study Details: 

Expected Total Enrollment:  450

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

Criteria

Inclusion Criteria:

• Recurrent or chronic major depressive disorder

Steven D. Hollon, PhD      615-343-4827    steven.d.hollon@vanderbilt.edu

Illinois
      Rush Medical Center - Treatment Research Unit, Chicago,  Illinois,  60612,  United States; Recruiting
Pennsylvania
      Depression Research Unit, University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Tennessee
      Vanderbilt Adult Outpatient Psychiatry, Nashville,  Tennessee,  37203,  United States; Recruiting

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   

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