Status:
COMPLETED
Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief 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 func...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00704379
Start Date
June 1 2008
End Date
April 1 2014
Last Update
August 25 2015
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030-4211