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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: | NCT00183664 |
This study will compare the effectiveness of cognitive therapy versus antidepressant medication in treating depression and preventing relapse in individuals with recurrent depression.
Condition | Intervention | Phase |
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Depression |
Drug: Fluoxetine Behavioral: Cognitive therapy (CT) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prophylactic Cognitive Therapy for Depression |
Estimated Enrollment: | 900 |
Study Start Date: | December 1999 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive continuation phase cognitive therapy for a total of 11 months of treatment
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Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
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2: Active Comparator
Participants will receive 3 months of cognitive therapy and then 8 months of treatment with the antidepressant fluoxetine hydrochloride
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Drug: Fluoxetine
Fluoxetine 10 to 40 mg/day for 8 months
Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
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3: Placebo Comparator
Participants will receive 3 months of cognitive therapy and then 8 months of treatment with placebo capsules
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Behavioral: Cognitive therapy (CT)
All participants will receive 16 to 20 individual sessions of CT for 3 months. Participants assigned to continuation phase will receive additional sessions every other week for 8 weeks and then monthly for 6 months.
Drug: Placebo
Placebo daily for 8 months
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Cognitive therapy (CT) is a form of therapy that focuses on changing negative thinking patterns and developing coping skills to deal with psychological problems. It encourages individuals to think, feel, and behave in a more positive manner. Previous research has shown that CT is effective for treating a number of psychological symptoms, including anxiety, anger, and loneliness. Many studies show that CT is, in fact, more effective than antidepressant medications for treating various psychological disorders. The "self-help" mentality and coping skills that are developed during CT tend to decrease the likelihood of depression relapse. While antidepressants often cause many unpleasant side effects such as dizziness, nausea, and increased heart rate, there are no known negative side effects associated with CT. The purpose of this study is to evaluate the effectiveness of CT versus antidepressant medication for treating depression and preventing relapse in individuals with recurrent depression.
This 36-month study will consist of three phases. During Months 1 through 3, participants will receive between 16 and 20 CT sessions. Participants will then be randomly assigned to receive additional CT sessions, antidepressant medication, or placebo for 8 months. Upon completing treatment, follow-up visits will occur once every 4 months for a total of 24 months. Outcome measurements will include standardized psychological tests and questionnaires to assess the participant's level of depression. All measurements will be assessed at Week 1, Week 12, and Months 8, 12, 16, 20, and 24.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marna S. Barnett, PhD | 215-746-6680 | msb@mail.med.upenn.edu |
Contact: Teresa Hinton | 215-746-6680 | hintont@mail.med.upenn.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Judith A. Callan, RN, MSN 412-246-5734 callanja@upmc.edu | |
Contact: Lisa M. Stupar 412-246-5757 stuparlm@upmc.edu | |
Principal Investigator: Michael E. Thase, MD | |
Sub-Investigator: Edward S. Friedman, MD |
Principal Investigator: | Michael E. Thase, MD | The University of Pittsburgh School of Medicine |
Responsible Party: | University of Pennsylvania School of Medicine ( Michael E. Thase ) |
Study ID Numbers: | R01 MH58356, DSIR 83-ATP |
Study First Received: | September 13, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00183664 |
Health Authority: | United States: Federal Government |
Depression Cognitive Therapy Relapse Prevention |
Fluoxetine Depression Mental Disorders Mood Disorders |
Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |