Using buspirone to manage irritability and aggression in traumatic brain injury patients
Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury
PHASE4 · Indiana University · NCT01821690
This study is testing if the medication buspirone can help reduce irritability and aggression in people who have had a traumatic brain injury.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT01821690 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of buspirone in reducing irritability and aggression in individuals who have experienced a traumatic brain injury (TBI). A total of 74 participants will be recruited and randomized to receive either buspirone or a placebo, with assessments conducted at four clinic visits over a 91-day period. The study will utilize various questionnaires to measure changes in behavior and mood, and will include a continuation phase where all participants receive buspirone. The goal is to develop a reliable measure of irritability and aggression impact post-TBI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have experienced a closed head injury at least 6 months prior and exhibit moderate to severe irritability.
Not a fit: Patients with stable neurological conditions who do not exhibit irritability or aggression may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve behavioral control and quality of life for patients with TBI.
How similar studies have performed: While there have been studies on behavioral interventions for TBI, the specific use of buspirone for irritability and aggression is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University and Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Flora Hammond, MD — Indiana University/Rehabilitation Hospital of Indiana
- Study coordinator: Rebecca Runkel, MHA
- Email: rrunkel@iu.edu
- Phone: (317) 329-2217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Buspirone, Behavior, Irritability, Aggression