Traumatic brain injury (TBI) is a leading cause of death and disability among young adults. Thefrequent cognitive, emotional and behavioral problems observed after TBI are major risk factorsinfluencing the outcome of TBI patients. Mood disorders are the most frequent psychiatriccomplication of TBI, have a large impact on family functioning, interpersonal relationships, andreturn to work or school. Furthermore, a significant proportion of these disorders will progress tomore chronic and treatment refractory forms. In spite of their clinical relevance, mood andanxiety disorders remain largely unrecognized and not adequately treated, contributing togreater disability and decreased participation in the aftermath of TBI. In this study, we willexamine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during thefirst six months after TBI. A group of 104 patients with closed TBI will be recruited immediatelyafter resolution of posttraumatic amnesia and randomly assigned to receive six months ofdouble-blind treatment with sertraline or placebo. Primary outcome measures will include time toonset of DSM-IV defined mood and anxiety disorders requiring immediate treatmentintervention, and psychosocial outcome as measured by Community Integration Questionnaire(CIQ) scores. In addition, we will examine the effect of sertraline on frequent post-TBIbehavioral disorders such as aggression, impulsivity, poor decision making and apatheticsymptoms. MRI based volumetry and diffusion tensor imaging will be used to examine thestructural correlates of mood and anxiety disorders as well biological predictors of treatmentresponse and community reintegration. Early preventive treatment with sertraline would reducesub-threshold mood and behavioral symptoms, prevent the occurrence of structural andfunctional brain changes associated with the onset of mood disorders, assure patient's accessand participation in rehabilitation programs and, consequently, improve psychosocial outcome.
Cognitive and behavioral disturbances are the most relevant long-term consequences oftraumatic brain injury (TBI); and are probably the most important factors affecting quality of lifeof these patients. In this study; we will examine the efficacy of sertraline to prevent the onset ofmood and anxiety disorders and examine whether early treatment with sertraline can improvebehavioral and psychosocial outcomes following TBI.
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