Buspirone for Irritability and Aggression in Traumatic Brain Injury

Study start date: May 15, 2013

Inclusion Criteria: Closed head injury (impaired brain function resulting from externally inflicted trauma without penetrating injury as defined below) at least 6 months prior to enrollment Irritability that is either new or worse than level of irritability before the traumatic brain injury, by report of observer or person with TBI Age at time of enrollment: 18 to 70 years Voluntary informed consent of patient and observer Subject and observer willing to comply with the protocol Observer-rated NPI Irritability Domain score 6 or greater to include only moderate-severe irritability Medically and neurologically stable during the month prior to enrollment. If taking antidepressant, anxiolytic, hypnotic, or stimulant medications, no change anticipated in these medications during the month prior to enrollment No change in therapies or medications planned during the 91-day participation No surgeries planned during the 91-day participation Vision, hearing, speech, motor function, and comprehension sufficient for compliance with all testing procedures and assessments Observer (e.g.: family member, close friend, employer) with whom subject interacts sufficiently to observe occurrences of irritability. The observer interacts with the participant for a period long enough and of a nature to be able to judge the participant's irritability. The interactions would need to be adequate to judge observer distress over the irritability, severity of irritability and frequency of irritability on the following scale: < once weekly; once per week; several times per week, but not every day; essentially continuous. Exclusion Criteria: Potential subject without a reliable observer Penetrating head injury as defined by head injury due to gunshot, projectile or foreign object Injury < 6 months prior to enrollment Ingestion of buspirone during the month prior to enrollment Inability to interact sufficiently for communication with caregiver History of schizophrenia or psychosis Diagnosis of progressive or additional neurologic disease Clinical signs of active infection