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

Launched by INDIANA UNIVERSITY · Mar 27, 2013

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called buspirone to help manage irritability and aggression in individuals who have experienced a traumatic brain injury (TBI). The goal is to see if this treatment can improve behavior control in people who have been dealing with increased irritability after their injury. The study is currently looking for participants aged 18 to 70 who have had a closed head injury at least six months ago and are experiencing moderate to severe irritability.

To participate, individuals must have someone, like a family member or friend, who can observe and report on their behavior. Participants should be in stable health and not planning to change their other medications or undergo surgery during the study period. If selected, they can expect to follow a 91-day treatment plan, where they will be monitored for any changes in their irritability and aggression. This trial is important because finding effective treatments for these challenging symptoms can significantly improve the quality of life for those affected by TBI.

Gender

ALL

Eligibility criteria

• 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