Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury Memantine Memory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

Detailed description:
This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI) persons, employing a randomized, double-blind, placebo-controlled, design. Outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

Arms:
arm 1: 24 weeks of memantine with accelerated titration, beginning within 48 hours of injury. arm 2: 24 weeks of placebo matched to memantine formulation, beginning within 48 hours of injury.

Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine. intervention 2: Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo.

Protocol document: