Mood disorders are very common after TBI, with both depression and anxiety disorders occurring at rates much higher than for the population at large, and having severe negative effects on participation and quality of life. This is a randomized clinical trial to determine the efficacy of sertraline (Zoloft) in the treatment of major depressive disorder (MDD) post TBI. Secondary goals are to determine the impact of sertraline on quality of life, and to explore the potential impact of sertraline on anxiety disorders post TBI. 50 subjects with MDD will be randomized to 12 weeks of treatment with Zoloft or placebo. They will complete a comprehensive battery of outcomes measures at baseline and after 12 weeks, and biweekly measures of depression and anxiety during the trial.
Registry Project Number: 430
Lead Investigator: Hibbard, M
Lead Center for Project: Mount Sinai School of Medicine
Collaborating Investigators: Cantor, J, Flanagan, S, Greenwald, B, Gordon, W, Ashman, T
Expected Completion: 09/30/2007
Status of Project: Latest Information Shown
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