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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 below
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I am between 18 and 70 years old.
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I have no surgeries planned for the next 3 months.
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I have been medically stable for the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 91
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 91 for reporting.

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 more

Side effects data

From 2016 Phase 4 trial • 175 Patients • NCT00875836
49%
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
980 Previous Clinical Trials
983,202 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)
2 Previous Clinical Trials
171 Total Patients Enrolled

Media Library

Buspirone (Anxiolytic) Clinical Trial Eligibility Overview. Trial Name: NCT01821690 — N/A
Traumatic Brain Injury Research Study Groups: Buspirone Treatment, Buspirone Placebo
Traumatic Brain Injury Clinical Trial 2023: Buspirone Highlights & Side Effects. Trial Name: NCT01821690 — N/A
Buspirone (Anxiolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01821690 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
Flora Hammond 2013. "Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01821690.
All > Tb > Traumatic Brain Injury
~4 spots leftby Dec 2024
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