Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion.

Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Methodist Rehabilitation Center
• Collaborator: U.S. Department of Education
• Treatments: Amantadine

Criteria

Inclusion Criteria:

• Acute Traumatic Brain Injury (≤90 days postinjury)

• Responsive (not fulfilling criteria for Minimally Conscious State)

• Meet PTCS criteria on 2 consecutive examinations (as determined by the Confusion Assessment Protocol)

• Initial neurorehabilitation hospital admission

• Anticipated ≥2 week length-of-stay after meeting PTCS criteria

Exclusion Criteria:

• Preexisting seizure disorder

• Prior history of hospitalization for psychiatric condition