Traumatic Brain Injury | Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
Traumatic Brain Injury research study
What is the primary objective of this study?
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 is eligible to participate?
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 or bipolar disorder - Diagnosis of progressive or additional neurologic disease - Clinical signs of active infection
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Traumatic Brain Injury
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:BuspironeBuspirone/placebo will be given in increasing increments of 15 mg as needed. Subjects will start with 15 mg on day one and end with 60 mg on day 91 or placebo equivalent. Dose is titrated based on treatment response.
Drug:PlaceboThe placebo tablets taste and look identical to buspirone.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Buspirone Treatmentstarting at 15 mg/day and ending at 60 mg/day as prescribed
Buspirone Placeboplacebo tablets as prescribed
Start Date: May 2013
Completed Date: December 2020
Primary Outcome: Neuropsychiatric Inventory-Irritability Domain
Secondary Outcome: Neuropsychiatric Inventory-Aggression Domain
Study sponsors, principal investigator, and references
Principal Investigator: Flora Hammond, MD
Lead Sponsor: Indiana University