At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 81 enrolled
Drug / intervention
Buspirone +1 moredrug
Likely dose
Buspirone 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury
In Brief
A Phase 4 clinical trial evaluating Buspirone and Placebo for Traumatic Brain Injury. Completed, enrolled 81 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionSep 2025
TodayJul 2026
First PostedApr 1, 2013
Enrollment StartMay 15, 2013
Primary CompletionSep 26, 2025
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 13.3 years ago
Interventions
Buspironedrug
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.
Placebodrug
The placebo tablets taste and look identical to buspirone.