A Double Blind Trial of Divalproex Sodium for Affective Lability and Alcohol Use Following Traumatic Brain Injury
Abstract
A large and under-recognized sub-set of patients suffer from both traumatic brain injury (TBI) and alcohol abuse/dependence (AA/D). This group appears to use alcohol to self-treat fronto-limbic disinhibition, expressed clinically as affective lability, following TBI. This often results in AA/D 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 propose an 8 week, double-blind, randomized, controlled trial comparing divalproex sodium to placebo in 50 subjects 25 per group--who suffer from both TBI and AA/D. Subjects will be 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 continues. There are no results to report at this time.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA597819
Entities
People
- Thomas P. Beresford
Organizations
- Denver Research Institute