Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00627250
Eligibility Criteria:
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 unavailable or incomplete
* DSM-IV diagnosis of schizophrenia or psychosis
* Diagnosis of progressive or additional neurologic disease (such as, Alzheimer's disease, parkinson's disease, multi-infarct dementia, other cerebrovascular disorders with dementia, prior cerebrovascular accident, Huntington's disease, olivopontocerebellar atrophy, multisystem atrophy, multiple sclerosis, ALS, CNS tumor, progressive supranuclear palsy).
* Diagnosis of seizure in the month prior to enrollment.
* Previous allergy or adverse reaction to study drug
* Ingestion of amantadine hydrochloride during the month prior to enrollment.
* Concomitant use of neuroleptic agents or phenelzine
* Creatinine clearance \<60
* Pregnancy (Beta-HCG performed on all females of child-bearing potential) and lactating females.
* Clinical signs of active infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT00627250
Study Brief:
Protocol Section:
NCT00627250