Preventing the Recurrence of Depression With Drugs and Psychotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

April 4, 2003

Last Updated Date

September 22, 2008

Start Date ^ICMJE

October 2002

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to remission (LIFE and HRSD) [ Time Frame: Measured at Month 18 of treatment ] [ Designated as safety issue: No ]
Time to recovery (LIFE and HRSD) [ Time Frame: Measured at Month 36 of treatment ] [ Designated as safety issue: No ]
Time to recurrence (LIFE and HRSD) [ Time Frame: Measured up to Month 36 from recovery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Time to remission (LIFE and HRSD) [ Time Frame: 18 months ]
Time to recovery (LIFE and HRSD) [ Time Frame: 18 months ]
Time to recurrence (LIFE and HRSD) [ Time Frame: 36 months ]

Change History

Complete list of historical versions of study NCT00057577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Preventing the Recurrence of Depression With Drugs and Psychotherapy

Official Title ^ICMJE

Prevention of Recurrence in Depression With Drugs and CT

Brief Summary

This study will 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.

Detailed Description

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Behavioral: Cognitive Therapy (CT)
Drug: Antidepressant medications

Study Arms / Comparison Groups

Experimental: Participants will receive antidepressant medication plus cognitive therapy
Experimental: Participants will receive maintenance of antidepressant medication alone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

450

Estimated Completion Date

March 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Recurrent or chronic major depressive disorder

Exclusion Criteria:

Current diagnosis of psychotic affective disorder
History of nonaffective psychotic disorder
Substance dependence last three months requiring detox
Schizotypal, antisocial, or borderline personality disorder

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057577

Responsible Party

Steven D. Hollon, PhD, Vanderbilt University

Study ID Numbers ^ICMJE

R01 MH60713, DSIR 83-ATAS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP