Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression (NCT00621751) | Clinical Trial Compass
CompletedNot Applicable
Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression
United States70 participantsStarted 2008-02
Plain-language summary
The purpose of this study is to determine if carbamazepine reduces irritability and aggression among individuals with traumatic brain injury
Who can participate
Age range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Closed head injury (defined as impaired brain function resulting from externally inflicted trauma without penetrating injury) at least 6 months prior to enrollment
* Age at time of enrollment: 16 to 75 years
* Voluntary informed consent of patient and informant
* Subject and informant willing to comply with the protocol
* Informant-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 42-day participation No surgeries planned during the 42-day participation Vision, hearing, speech, motor function, and comprehension sufficient for compliance with all testing procedures and assessments
* Informant (e.g. family member or close friend) with daily interaction in order to observe occurrences of irritability
Exclusion Criteria:
* Potential subject without a reliable informant
* Penetrating head injury
* Injury \< 6 months prior to enrollment
* Ingestion of carbamazepine during the month prior to enrollment
* Inability to interact sufficiently for communication with caregiver
* Acute and rehabilitation records unavailable or incomplete
* Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of schizophrenia or psychos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.