Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00704379
- Run by
- Baylor College of Medicine
- People needed
- 94
- Starts
- 2008-06-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-08-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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