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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00057577 |
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 |
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Depression |
Behavioral: Cognitive Therapy (CT) Drug: Antidepressant medications |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Recurrence in Depression With Drugs and CT |
Enrollment: | 450 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive antidepressant medication plus cognitive therapy
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Behavioral: Cognitive Therapy (CT)
CT sessions occur weekly during acute treatment and monthly during continuation. Treatment may last 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 CT.
Drug: Antidepressant medications
Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Treatment may last up to 18 months. Remitted patients are continued on medication for up to another 18 months 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.
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2: Experimental
Participants will receive maintenance of antidepressant medication alone
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Drug: Antidepressant medications
Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Treatment may last up to 18 months. Remitted patients are continued on medication for up to another 18 months 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.
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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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Responsible Party: | Vanderbilt University ( Steven D. Hollon, PhD ) |
Study ID Numbers: | R01 MH60713, DSIR 83-ATAS |
Study First Received: | April 4, 2003 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00057577 |
Health Authority: | United States: Federal Government |
Depression Mental Disorders Mood Disorders |
Depressive Disorder Recurrence Behavioral Symptoms |