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Anxiolytic
Buspirone for Traumatic Brain Injury Irritability and Aggression
N/A
Recruiting
Led By Flora Hammond, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age at time of enrollment: 18 to 70 years
No surgeries planned during the 91-day participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 91 day
Awards & highlights
Study Summary
This trial will test different treatments to see which is most effective in reducing irritability and aggression in people who have suffered a traumatic brain injury.
Who is the study for?
This trial is for adults aged 18-70 with traumatic brain injury (TBI) who have experienced increased irritability or aggression since their injury, which occurred at least 6 months prior. Participants must not plan any medication changes during the study and need a reliable observer to report on their behavior.Check my eligibility
What is being tested?
The trial tests whether Buspirone, a medication typically used for anxiety, can help control post-TBI irritability and aggression compared to a placebo. Patients will be randomly assigned to receive either Buspirone or an inactive pill.See study design
What are the potential side effects?
Buspirone may cause side effects such as dizziness, nausea, headache, nervousness, lightheadedness, excitement, and trouble sleeping. The severity of these side effects varies from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
I have no surgeries planned for the next 3 months.
Select...
I have been medically stable for the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 91
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 91
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neuropsychiatric Inventory-Irritability Domain
Secondary outcome measures
Aggression and Irritability Impact Measure
Clinical Global Impressions
Generalized Anxiety Disorder
+7 moreSide effects data
From 2016 Phase 4 trial • 175 Patients • NCT0087583649%
Other
41%
Dizziness or lightheaded
41%
Gastrointestinal
32%
Headache
22%
Congestion
19%
Drowsiness
18%
Insomnia
15%
Sinus/allergies/flu
13%
Musculoskeletal
5%
Anxiety or Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Buspirone
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Buspirone TreatmentExperimental Treatment1 Intervention
starting at 15 mg/day and ending at 60 mg/day as prescribed
Group II: Buspirone PlaceboPlacebo Group1 Intervention
placebo tablets as prescribed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buspirone
2022
Completed Phase 4
~1160
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
988 Previous Clinical Trials
1,091,124 Total Patients Enrolled
Flora Hammond, MDPrincipal Investigator - Indiana University/Rehabilitation Hospital of Indiana
IU Health Ball Memorial Hospital, IU Health Methodist Hospital, IU Health North Hospital, Rehabilitation Hospital of Indiana
Tulane University School Of Medicine (Medical School)
Baylor College Of Medicine (Residency)
3 Previous Clinical Trials
211 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have someone close who can report on my irritability regularly.I have taken buspirone in the last month.I have no surgeries planned for the next 3 months.I am showing signs of an active infection.I had a head injury more than 6 months ago.I am more irritable since my brain injury.I am not planning to change my mental health medications before joining the study.I am willing to follow the study's rules.My neurological condition is getting worse.I am between 18 and 70 years old.I have had a head injury caused by a gunshot, projectile, or foreign object.I struggle to communicate effectively with my caregiver.I have been medically stable for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Buspirone Treatment
- Group 2: Buspirone Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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