Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Mood Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Sertraline
Intervention type(s): Drug; Drug
Intervention description(s): an inactive substance; Sertraline and placebo will be given in a double blind fashion via an equal number of identical tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention. Blood samples will be obtained randomly, one during the first and one during the second trimesters of the protocol.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: traumatic brain injury; TBI; mood disorders; anxiety disorders; community reintegration; executive function; sertraline; diffusion tensor imaging