Carbamazepine for the Treatment of Chronic Post-TBI Irritability and Aggression: A 42-day Single-site, Forced-titration, Parallel Group, Randomized, Double-blind, Placebo-controlled Trial

The proposed research focuses on the challenging problem of post-traumatic irritability (primary aim) and aggression (secondary aim) using a comprehensive, rigorous approach to generate and disseminate new knowledge on this high impact, pervasive, and under-studied problem that affects approximately 29-71% of individuals with traumatic brain injury (TBI). Our approach to understanding irritability entails a randomized, controlled study of the effect of carbamazepine on chronic TBI irritability and aggression. The current literature does not support Standards or Guidelines for the management of TBI irritability and aggression. The proposed systematic research on irritability and aggression addresses the critical gap in the evidence-based treatment of post-TBI behavioral issues by producing new scientific knowledge that contributes to standards of care in this area. In addressing this pervasive problem that impedes psychosocial functioning, the project undertakes the National Institute on Disability and Rehabilitation Research Long-Range Plan areas of “Health & Function” and “Full Access to Community Life.”