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A Double Blind Trial of Divalproex Sodium for Affective Liability and Alcohol Use Following Traumatic Brain Injury

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Technical Report,15 Sep 2014,14 Oct 2015

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Denver Research Institute Denver United States

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A large and under-recognized sub-set of patients suffer from both traumatic brain injury TBI and alcohol abusedependence AAD. This group appears to use alcohol to self-treat fronto-limbic disinhibition, expressed clinically as affective lability, following TBI. This often results in AAD and worsens TBI prognosis. The primary study hypothesis states that symptom frequencies of fronto-limbic disinhibition, expressed as affective lability, will decrease significantly in TBI subjects treated with divalproex sodium, a mood stabilizing medication, as compared to placebo. To test the primary hypothesis, we conducted an 8 week, double-blind, randomized, controlled trial comparing divalproex sodium to placebo in 50 subjects25 per group--who suffer from both TBI and AAD. Subjects were recruited through the initiating site located at the Department of Veterans Affairs Medical Center, Denver. Final approval from multiple review bodies was granted on September 15, 2009. Active subject recruitment and all subject follow-up is complete. There are preliminary results to report at this time.


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