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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01821690
• Other study ID #: 1210009885
• Secondary ID: CFDA #: 84.133A-
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: Rebecca Runkel, MHA
• Phone: (317) 329-2217
• Email: becky.runkel[@]rhin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PURPOSE OF PROJECT: To study the effect expressed by persons with TBI through assessment of buspirone effectiveness for post-traumatic irritability and aggression and development of an irritability/aggression impact measure.

SUMMARY OF PROJECT: It is anticipated that 74 subjects with 74 corresponding subject observers will be recruited for the treatment study. Subjects will be recruited from community and self-referrals.

Interested potential participants will be scheduled for an in-person screening visit. Subjects who consent and qualify will be randomized in a 1:1 ratio, buspirone or placebo. Stratification to randomization group will occur based on the presence of major or minor depression (defined by PHQ-9 total score >5). Randomized subjects will receive active treatment or placebo. There will be 4 clinic visits. Visits will occur at baseline, for consenting and screening, day 35, day 63 and day 91. At all 4 clinic visits, both the subject and the observer will be given questionnaires regarding the subject's behavior and mood. Day 91 ends the period of the randomized clinical trial phase of the study and the subjects will begin the 1 month continuation phase of the study in which all participants receive active buspirone.

The following questionnaires will be used as measures of irritability and aggression for the subject and the observer: Neuropsychiatric Inventory (NPI & NPI-Distress), Aggression & Irritability Impact Measure (AIIM) and Global Impression of Change.

The following questionnaires will be dispensed to the subject only: TBI-Quality of Life-Anger, Personal Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), PTSD Checklist Civilian (PCL-C), and Glasgow Outcome Scale Extended (GOS-E) The Investigator will complete the Clinical Global Impression of change at Visits 1, 2, 3, and 4. History and Physical Exam, creatinine level (kidney function) and liver function tests will be obtained for eligibility. Serum pregnancy tests will be drawn at screening for females of childbearing potential.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aggression
• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• Placebo
The placebo tablets taste and look identical to buspirone.

Locations

Country	Name	City	State
United States	Indiana University and Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychiatric Inventory-Irritability Domain	A self-report measure of irritability	Day 91
Secondary	Neuropsychiatric Inventory-Aggression Domain	A self-report measure of aggression	Day 91
Secondary	Neuropsychiatric Inventory-Distress Irritability Domain	A self-report measure of the distress caused by irritability	Day 91
Secondary	Neuropsychiatric Inventory-Distress Aggression Domain	A self-report measure of the distress caused by aggression	Day 91
Secondary	St. Andrews-Swansea Neurobehavioural Outcome Scale	A self-report measure of overall neurobehavioral function	Day 91
Secondary	Personal Health Questionnaire	A measure of depression that maps on to DSM criteria for depression	Day 91
Secondary	Traumatic Brain Injury-Quality of Life Anger	A self-report measure of overall impact of anger on quality of life	Day 91
Secondary	Global Impressions of Change	A self-report measure of overall change	Day 91
Secondary	Clinical Global Impressions	Clinician rating of overall change	Day 91
Secondary	Aggression and Irritability Impact Measure	A self-report measure of overall impact of irritability on life participation	91 Day
Secondary	Generalized Anxiety Disorder	A self-report measure of anxiety	91 day

External Links

•   Indiana University School of Medicine
•   Rehabilitation Hospital of Indiana