Traumatic Brain Injury Clinical Trial
Official title:
Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
Traumatic brain injury (TBI) is a leading cause of death and disability among young adults.
Mood disorders are the most frequent psychiatric complication of TBI, and have a large
impact on family functioning, interpersonal relationships, and ability to return to work or
school. Furthermore, a significant proportion of these disorders will progress to more
chronic and treatment refractory forms. In spite of their clinical relevance, mood and
anxiety disorders remain largely unrecognized and not adequately treated, contributing to
greater disability and decreased participation in the aftermath of TBI.
The goals of this study are to learn more about how people recover from brain injury and to
evaluate the effect of sertraline (also known as Zoloft) compared to placebo (an inactive
substance) in preventing the occurrence of emotional and behavioral problems—such as
depression, lack of motivation, anxiety, irritability or aggressive outbursts—following TBI.
In the study, a group of 104 participants with TBI—recruited immediately after resolution of
posttraumatic amnesia—will be randomly assigned to receive six months of double-blind
treatment with sertraline or placebo.
This study will determine how these emotional and behavioral problems influence thinking,
physical recovery, and return to a productive life six months after brain injury.
Researchers will also determine if certain brain changes can predict the occurrence of
behavioral problems and if treatment with sertraline can prevent them. Additionally, the
researchers will examine the effect of sertraline on frequent post-TBI behavioral disorders
such as aggression, impulsivity, poor decision making and apathetic symptoms.
Magnetic resonance imaging (MRI)-based volumetry and diffusion tensor imaging will be used
to examine the structural correlates of mood and anxiety disorders and to evaluate them as
biological predictors of treatment response and community reintegration. The researchers
hypothesize that early preventive treatment with sertraline will reduce mood and behavioral
symptoms, prevent the occurrence of structural and functional brain changes associated with
the onset of mood disorders, increase access to and participation in rehabilitation programs
for TBI, and, consequently, improve psychosocial outcome.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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