Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01821690|
Recruitment Status : Recruiting
First Posted : April 1, 2013
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Buspirone Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Buspirone Treatment
starting at 15 mg/day and ending at 60 mg/day as prescribed
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.
Other Name: Buspar
Placebo Comparator: Buspirone Placebo
placebo tablets as prescribed
The placebo tablets taste and look identical to buspirone.
- Neuropsychiatric Inventory-Irritability Domain [ Time Frame: Day 91 ]A self-report measure of irritability
- Neuropsychiatric Inventory-Aggression Domain [ Time Frame: Day 91 ]A self-report measure of aggression
- Neuropsychiatric Inventory-Distress Irritability Domain [ Time Frame: Day 91 ]A self-report measure of the distress caused by irritability
- Neuropsychiatric Inventory-Distress Aggression Domain [ Time Frame: Day 91 ]A self-report measure of the distress caused by aggression
- St. Andrews-Swansea Neurobehavioural Outcome Scale [ Time Frame: Day 91 ]A self-report measure of overall neurobehavioral function
- Personal Health Questionnaire [ Time Frame: Day 91 ]A measure of depression that maps on to DSM criteria for depression
- Traumatic Brain Injury-Quality of Life Anger [ Time Frame: Day 91 ]A self-report measure of overall impact of anger on quality of life
- Global Impressions of Change [ Time Frame: Day 91 ]A self-report measure of overall change
- Clinical Global Impressions [ Time Frame: Day 91 ]Clinician rating of overall change
- Aggression and Irritability Impact Measure [ Time Frame: 91 Day ]A self-report measure of overall impact of irritability on life participation
- Generalized Anxiety Disorder [ Time Frame: 91 day ]A self-report measure of anxiety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821690
|Contact: Rebecca Runkel, MHA||(317) firstname.lastname@example.org|
|Contact: Kelsey Hurm, MA||(317) email@example.com|
|United States, Indiana|
|Indiana University and Rehabilitation Hospital of Indiana||Recruiting|
|Indianapolis, Indiana, United States, 46254|
|Contact: Flora Hammond, MD 317-329-2106 firstname.lastname@example.org|
|Contact: Rebecca Runkel, MHA 317-329-2217 email@example.com|
|Principal Investigator: Flora Hammond, MD|
|Principal Investigator:||Flora Hammond, MD||Indiana University/Rehabilitation Hospital of Indiana|