Status:
COMPLETED
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
Lead Sponsor:
Indiana University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
PURPOSE OF PROJECT: To study the effect expressed by persons with TBI through assessment of buspirone effectiveness for post-traumatic irritability and aggression and development of an irritability/ag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01821690
Start Date
May 15 2013
End Date
September 26 2025
Last Update
November 20 2025
Active Locations (1)
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1
Indiana University and Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254