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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Buspirone, Behavior, Irritability, Aggression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University and Rehabilitation Hospital of IndianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Buspirone Treatment

Buspirone Placebo

Arm Description

starting at 15 mg/day and ending at 60 mg/day as prescribed

placebo tablets as prescribed

Outcomes

Primary Outcome Measures

Neuropsychiatric Inventory-Irritability Domain
A self-report measure of irritability

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2013
Last Updated
February 27, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01821690
Brief Title
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
Official Title
Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Buspirone, Behavior, Irritability, Aggression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Buspirone Treatment
Arm Type
Experimental
Arm Description
starting at 15 mg/day and ending at 60 mg/day as prescribed
Arm Title
Buspirone Placebo
Arm Type
Placebo Comparator
Arm Description
placebo tablets as prescribed
Intervention Type
Drug
Intervention Name(s)
Buspirone
Other Intervention Name(s)
Buspar
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo tablets taste and look identical to buspirone.
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory-Irritability Domain
Description
A self-report measure of irritability
Time Frame
Day 91
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory-Aggression Domain
Description
A self-report measure of aggression
Time Frame
Day 91
Title
Neuropsychiatric Inventory-Distress Irritability Domain
Description
A self-report measure of the distress caused by irritability
Time Frame
Day 91
Title
Neuropsychiatric Inventory-Distress Aggression Domain
Description
A self-report measure of the distress caused by aggression
Time Frame
Day 91
Title
St. Andrews-Swansea Neurobehavioural Outcome Scale
Description
A self-report measure of overall neurobehavioral function
Time Frame
Day 91
Title
Personal Health Questionnaire
Description
A measure of depression that maps on to DSM criteria for depression
Time Frame
Day 91
Title
Traumatic Brain Injury-Quality of Life Anger
Description
A self-report measure of overall impact of anger on quality of life
Time Frame
Day 91
Title
Global Impressions of Change
Description
A self-report measure of overall change
Time Frame
Day 91
Title
Clinical Global Impressions
Description
Clinician rating of overall change
Time Frame
Day 91
Title
Aggression and Irritability Impact Measure
Description
A self-report measure of overall impact of irritability on life participation
Time Frame
91 Day
Title
Generalized Anxiety Disorder
Description
A self-report measure of anxiety
Time Frame
91 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Runkel, MHA
Phone
(317) 329-2217
Email
becky.runkel@rhin.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flora Hammond, MD
Organizational Affiliation
Indiana University/Rehabilitation Hospital of Indiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University and Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Hammond, MD
Phone
317-329-2106
Email
flora.hammond@rhin.com
First Name & Middle Initial & Last Name & Degree
Rebecca Runkel, MHA
Phone
317-329-2217
Email
becky.runkel@rhin.com
First Name & Middle Initial & Last Name & Degree
Flora Hammond, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data will be available upon request 24 months after completion of the project. Data requests should be submitted to the principal investigator.
Links:
URL
http://rhin.com
Description
Rehabilitation Hospital of Indiana
URL
http://medicine.iu.edu
Description
Indiana University School of Medicine

Learn more about this trial

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

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