Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression

Inclusion Criteria:

• Closed head injury (impaired brain function resulting from externally inflictedtrauma without penetrating injury as defined below) at least 6 months prior toenrollment

• Irritability that is either new or worse than level of irritability before thetraumatic 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 onlymoderate-severe irritability

• Medically and neurologically stable during the month prior to enrollment.

• If taking antidepressant, anxiolytic, hypnotic, or stimulant medications, no changeanticipated 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 compliancewith all testing procedures and assessments

• Observer (e.g.: family member, close friend, employer) with whom subject interactssufficiently to observe occurrences of irritability. The observer interacts with theparticipant for a period long enough and of a nature to be able to judge theparticipant's irritability. The interactions would need to be adequate to judgeobserver distress over the irritability, severity of irritability and frequency ofirritability on the following scale: < once weekly; once per week; several times perweek, 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 orforeign 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