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Can a common anxiety drug tame Post-TBI anger?
NCT ID NCT01821690
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested whether buspirone (Buspar), a drug used for anxiety, can reduce irritability and aggression in people who have had a traumatic brain injury. 81 adults with a closed head injury at least 6 months prior took either buspirone or a placebo for 91 days. The goal was to see if the drug improved behavior control, measured by changes in irritability and aggression scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- buspirone (Buspar)
- What this could lead to
- If it works, this could point toward a medication option to help people with traumatic brain injury manage irritability and aggression.
- What could go wrong
- This is a small, completed phase 4 trial with 81 participants. The results may not apply to everyone, and buspirone can cause side effects like dizziness or nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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81 people
The number who actually took part.
- Started
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May 2013
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana University and Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254, United States
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Other studies related to the condition(s) this trial covers.
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