Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression (NCT01821690) | Clinical Trial Compass
CompletedPhase 4
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
United States81 participantsStarted 2013-05-15
Plain-language summary
The purpose of this study is to improve behavior control displayed by persons with traumatic brain injury by assessing effectiveness of treatments for post-TBI irritability and aggression.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 frequ…