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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Institute of Disability and Rehabilitation Research |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00233103 |
Randomized clinical trial of sertraline vs. placebo for post-TBI depression
Condition | Intervention | Phase |
---|---|---|
Depression |
Drug: Sertraline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Post-TBI Depression |
Estimated Enrollment: | 50 |
Study Start Date: | June 2003 |
Study Completion Date: | October 2007 |
Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression.
Background: Major depression is experienced by many more people after TBI than prior to injury and more often than in people without a brain injury. Many studies have also shown that this higher than 'normal' incidence looms for many years post TBI. Major depression is associated with a variety of negative outcomes, including poorer functioning in basic activities, reduced employment, elevated divorce rate, reduced social and recreational activity and increased sexual dysfunction.
Need for Research: Of the current drug treatments for major depression, sertraline and similar drugs (known as selective serotonin reuptake inhibitors, or SSRIs) have few side effects in people who have experienced a brain injury and have been shown to be effective in people with no known brain injury. However, information on the impact of SSRIs on post-TBI depression, based on randomized, double-blind studies, is unavailable.
Current Research Activity: Approximately 50 men and women volunteers who are post TBI and currently diagnosed with major depressive disorder are being randomly assigned to a 12-week period of taking Zoloft or a placebo. Over the period of study, participants will have the severity of their depressive symptoms assessed (as well as their symptoms of anxiety); a simple measure of the volunteer's perceived quality of life will be implemented prior to the study and at its termination. It is hypothesized that sertraline will reduce the symptoms of depression and anxiety and will increase the person's perceived quality of life to a significantly greater extent than will the placebo.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Criteria for inclusion in the study are: 1) 18 years or older; 2) experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging); 3) at least 6 months post-injury; 4) English-speaking; 5) residential telephone service; 6) living within 1.5 hours of NYC; 6) able to comprehend or answer verbal or written questionnaires; 7) willing to provide consent to participate in a 12 week drug study to treat MDD; current MDD as diagnosed using SCID, and severity of MDD rated at least 18 on the HAM-D.
Exclusion Criteria:
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 |
Principal Investigator: | Wayne Gordon, Ph.D. | Nount Sinai School of Medicine |
Study ID Numbers: | GCO 02-0677, H133A020501 |
Study First Received: | October 3, 2005 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00233103 |
Health Authority: | United States: Institutional Review Board |
Setraline TBI depression SSRI brain injury |
Depression Mental Disorders Mood Disorders Sertraline |
Depressive Disorder Brain Injuries Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |