Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- * 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
Ages Eligible for Study
18 Years to 70 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No