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Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression

NCT01821690 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-02-24

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Buspirone

Buspirone/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

Placebo

The placebo tablets taste and look identical to buspirone.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Flora Hammond, MD · Indiana University/Rehabilitation Hospital of Indiana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-15
Primary Completion
2025-09-26
Completion
2025-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01821690 on ClinicalTrials.gov