“The AIMS Study”
A Multi-center, Parallel-Group, Randomized, Double-blind, Placebo-controlled Trial of Amantadine Hydrochloride in the Treatment of Chronic TBI Irritability and Aggression: A Replication Study
Principal Investigator: Kathleen Bell, MD
Researchers at the Department of Rehabilitation Medicine at the University of Washington are seeking volunteers for a research study. The purpose of the study is to see if amantadine is effective in treating irritability in patients with Traumatic Brain Injury.
There will be no cost to participants for the study medication or any of the office visits, tests or procedures associated with the study. Volunteers will receive compensation for each of the 3 study clinic visits to support their travel to and from each clinic visit.
Volunteers will be asked to take either amantadine or a placebo (sugar pill) twice a day for 60 days. At day 60, all the volunteers will begin taking amantadine twice a day for one more month. We also enroll an ‘observer’ in the study, defined as someone the subject has contact with at least five times per week.
Possible volunteers are:
Ø People between the ages of 18-75 who have had a Traumatic Brain Injury (TBI) more than 6 months ago.
Ø At least moderately irritable (easily annoyed or upset, poor temper control, may have verbal or physical outbursts).
Participation in the study will last for 90 days, and will involve:
Ø 3 in-person clinic visits at the University of Washington Medical Center lasting about 2 hours each.
Ø 10 telephone calls from study staff to check on how the volunteer is doing with the medicine. These calls will last about 20 minutes.
Ø Participants will receive $25 for each clinic visit.