Preventing the Recurrence of Depression With Drugs and Psychotherapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Depression	Behavioral: Cognitive Therapy (CT) Drug: Antidepressant medications	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Prevention of Recurrence in Depression With Drugs and CT

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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 ]

Other Outcome Measures:

serious adverse events [ Time Frame: throught the trial ] [ Designated as safety issue: Yes ]
serious adverse events as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study

Enrollment:	450
Study Start Date:	October 2002
Estimated Study Completion Date:	March 2014
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will receive antidepressant medication plus cognitive therapy	Behavioral: Cognitive Therapy (CT) CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT. Other Name: CT Drug: Antidepressant medications Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. 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.
Experimental: 2 Participants will receive maintenance of antidepressant medication alone	Drug: Antidepressant medications Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. 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.

Arms

Assigned Interventions

Experimental: 1

Participants will receive antidepressant medication plus cognitive therapy

Behavioral: Cognitive Therapy (CT)

CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.

Other Name: CT

Drug: Antidepressant medications

Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. 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.

Experimental: 2

Participants will receive maintenance of antidepressant medication alone

Drug: Antidepressant medications

Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. 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.

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 36 months from the point of initial randomization 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057577

Locations

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

Sponsors and Collaborators

Vanderbilt University

National Institute of Mental Health (NIMH)

Investigators

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

More Information

No publications provided

Responsible Party:	Steven Hollon, Professor of Psychology, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00057577 History of Changes
Other Study ID Numbers:	R01 MH60713, R01MH060713, DSIR 83-ATAS
Study First Received:	April 4, 2003
Last Updated:	March 26, 2013
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Depression
Depressive Disorder
Recurrence
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes

Pathologic Processes
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013