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

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ClinicalTrials.gov Identifier: NCT00057577
Recruitment Status : Completed
First Posted : April 8, 2003
Results First Posted : April 2, 2015
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven Hollon, Vanderbilt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive Therapy Drug: Medications Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Recurrence in Depression With Drugs and CT
Study Start Date : October 2002
Actual Primary Completion Date : July 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057577


Locations
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Steven Hollon, Professor of Psychology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00057577    
Other Study ID Numbers: R01MH060713 ( U.S. NIH Grant/Contract )
R01MH060713 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2003    Key Record Dates
Results First Posted: April 2, 2015
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Recurrence
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes