Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability (NCT00627250) | Clinical Trial Compass
CompletedNot Applicable
Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability
76 participantsStarted 2003-03
Plain-language summary
The purpose of this study is to determine if amantadine hydrochloride given 100 mg in the morning and at noon is safe and effective in the treatment of mood and behavior changes (i.e. irritability) after sustaining traumatic brain injury.
Who can participate
Age range16 Years – 65 Years
SexALL
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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 brain injury or impaired brain function resulting from externally inflicted trauma without penetrating injury) at least 6 months prior to enrollment.
* Age at time of enrollment: 16 - 65 inclusive (i.e., on or after 16th birthday, up to day before 66th birthday).
* Voluntary informed consent of patient and informant.
* Subject and informant willing to comply with the protocol, \& are available for all scheduled clinic visits.
* Neuropsychiatric Inventory (NPI) Irritability Domain score \> 2.
* 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 28-day participation.
* No surgeries planned during the 28-day participation.
* Vision, hearing, speech, motor function, and comprehension must be sufficient for compliance with all testing procedures. Ability to interact and verbalize sufficient to participate in assessments.
* Informant (family member or close friend) who lives with the participant with daily interaction in order to observe occurrences of irritability.
Exclusion Criteria:
* Patients without a reliable informant
* Penetrating head injury
* Injury \< 6 months prior to enrollment
* Inability to interact sufficient for communication with caregiver
* Acute and rehabilitation records …
What they're measuring
1
Neuropsychiatric Inventory (Irritability Domain frequency and severity)