Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Age 18 years or over.

• Meeting the Center for Disease Control (CDC) criteria for TBI.

• Mild, Moderate, or Severe TBI as categorized by initial Glasgow Coma Scale (GCS) scores 13 to 15, 9 to 12, or 3 to 8, respectively.

• Complete recovery from Post Traumatic Amnesia (PTA) within 4 weeks of the traumatic episode.

Exclusion Criteria:

• Penetrating head injuries.

• Clinical or neuro-radiological evidence of associate spinal cord injury.

• Patients with severe comprehension deficits (i.e., those who are not able to complete part II of the Token Test) that precludes a thorough neuropsychiatric evaluation.

• Presence of Diagnostic and Statistical Manual IV defined mood, anxiety or psychotic disorder at the time of enrollment to the study. However, patients with a history of alcohol abuse or alcohol dependence during the year preceding TBI will be included in the study.

• Patients who were taking antidepressants at the time of TBI or during a six month period prior to the traumatic event.

• Patients who have failed an adequate previous trial with sertraline or had side effects that prompted the discontinuation of this medication.

• Pregnant women or women that plan to become pregnant during the period of the study.

• Severe complicating illness such as neoplastic disease or uncompensated heart, renal or liver failure.