Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Brain Research in Aggression and Irritability Network (BRAIN): Building Evidence-Based Approaches to Managing Traumatic Brain Injury|
- Neuropsychiatric Inventory-Irritability Domain [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory-Aggression Domain [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory-Distress Irritability Domain [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Neuropsychiatric Inventory-Distress Aggression Domain [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- St. Andrews-Swansea Neurobehavioural Outcome Scale [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Personal Health Questionnaire [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Traumatic Brain Injury-Quality of Life Anger [ Time Frame: Day 91 ] [ Designated as safety issue: Yes ]
- Global Impressions of Change [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Clinical Global Impressions [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
- Aggression and Irritability Impact Measure [ Time Frame: 91 Day ] [ Designated as safety issue: No ]
- Generalized Anxiety Disorder [ Time Frame: 91 day ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821690
|Contact: Rebecca Runkel, MHA||(317) email@example.com|
|Contact: Kara Jodry, BA||(317) firstname.lastname@example.org|
|United States, Indiana|
|Indiana University and Rehabilitation Hospital of Indiana||Recruiting|
|Indianapolis, Indiana, United States, 46254|
|Contact: Flora Hammond, MD 317-329-2106 email@example.com|
|Contact: Rebecca Runkel, MHA 317-329-2217 firstname.lastname@example.org|
|Principal Investigator: Flora Hammond, MD|
|Principal Investigator:||Flora Hammond, MD||Indiana University/Rehabilitation Hospital of Indiana|