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Prevention of Recurrence in Depression With Drugs and CT (CPT3)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Hollon, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00057577
First received: April 4, 2003
Last updated: May 22, 2017
Last verified: May 2017
  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 Drug: Medications Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Prevention of Recurrence in Depression With Drugs and CT

Further study details as provided by Steven Hollon, Vanderbilt University:

Primary Outcome Measures:
  • Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Through month 18 of treatment ]
    Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)

  • Number of Participants in Recovery According to the LIFE and HRSD [ Time Frame: Through 36 months of treatment ]
    Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)

  • Number of Participants in Recurrence According to the LIFE and HRSD [ Time Frame: Measured up to Month 36 from recovery ]
    Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)


Other Outcome Measures:
  • Serious Adverse Events [ Time Frame: Throughout study, up to 54 months ]
    Number Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study


Enrollment: 452
Study Start Date: October 2002
Study Completion Date: March 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive therapy plus medications
Participants will receive antidepressant medication plus cognitive therapy
Behavioral: Cognitive Therapy
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: 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.
Other Name: ADM
Experimental: Medications alone
Participants will receive maintenance of antidepressant medication alone
Drug: 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.
Other Name: ADM

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Hollon, Professor of Psychology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00057577     History of Changes
Other Study ID Numbers: R01MH060713 ( U.S. NIH Grant/Contract )
Study First Received: April 4, 2003
Results First Received: December 18, 2013
Last Updated: May 22, 2017

Additional relevant MeSH terms:
Depression
Depressive Disorder
Recurrence
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 16, 2017