COMPLETED

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

Conditions

Traumatic Brain Injury Buspirone Behavior Irritability Aggression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury

Quick Facts

Study Start:2013-05-15

Study Completion:2025-09-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT01821690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Flora Hammond, MD

PRINCIPAL_INVESTIGATOR

Indiana University/Rehabilitation Hospital of Indiana

Study Locations (Sites)

Indiana University and Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254

United States

Collaborators and Investigators

Sponsor: Indiana University

Flora Hammond, MD, PRINCIPAL_INVESTIGATOR, Indiana University/Rehabilitation Hospital of Indiana

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-05-15

Study Completion Date2025-09-26

Study Record Updates

Study Start Date2013-05-15

Study Completion Date2025-09-26

Terms related to this study

Keywords Provided by Researchers

Traumatic Brain Injury
Buspirone
Behavior
Irritability
Aggression

Additional Relevant MeSH Terms

Traumatic Brain Injury