Status:
COMPLETED
Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Irritable Mood
Aggression
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief 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) af...
Detailed Description
Amantadine hydrochloride is a drug used commonly in clinical practice at the Carolinas Rehabilitation for the treatment of mood and behavior changes following traumatic brain injury. Clinical observat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00627250
Start Date
March 1 2003
End Date
November 1 2007
Last Update
April 25 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.