Post-TBI Irritability and Aggression: Building Evidence-Based Approaches to Management
Flora Hammond, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
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. The goal is 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.
Detailed description of study
What will happen during the study?
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.
Additional Information:
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Traumatic brain injury, TBI
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Age: 18 years - 70 years
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Gender: All
Closed head injury at least 6 months prior to enrollment
Irritability/aggression
Observer with whom subject interacts sufficiently to observe occurences of irritability
Ingestion of buspirone during the month prior to enrollment
History of schizophrenia or psychosis
Uncontrolled seizure disorder
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