Poster 13: Prevention of Depression and Enhancing Cognitive Recovery in Traumatic Brain Injury With Duloxetine: Preliminary Results

Objective: To determine if duloxetine prevents depression and improves cognitive recovery following traumatic brain injury (TBI). Design: Double-blind, randomized, placebo-controlled study. Setting: Acute rehabilitation hospital. Participants: 6 subjects randomly assigned to the duloxetine (n=4) and placebo (n=2) groups. Interventions: Participants randomized to the duloxetine group received 30mg of duloxetine every day for 1 week and then 60mg every day for 9 months. Main Outcome Measures: Hamilton Depression Scale (HAM-D), Hopkins Verbal Learning Test (HVLT), and the Community Integration Questionnaire (CIQ). Results: Given the small sample size, the results are preliminary. HAM-D scores for all participants were notably low. Participants who received duloxetine demonstrated consistently better performance on the HVLT total recall and delayed recall subtests over the follow-up periods, with the significant differences from placebo at 6 months for the HVLT total recall subtest (2-tailed t test, P=.06) and for the delayed recall subtest (2-tailed t test, P=.03). The duloxetine group subjects rated themselves consistently better on the CIQ. The 9-month follow-up comparison demonstrated that the duloxetine group was superior to placebo (2-tailed t test, P=.007) on the CIQ productivity subscale. Conclusions: While preliminary, these data suggest that duloxetine may be effective in improving community participation and return to work or school after TBI. Results also suggest improved cognitive recovery, particularly with respect to verbal memory and learning capacity. No long-term advantage for the duloxetine group was found in terms of depression, but it was also noteworthy that levels of depression for both groups were remarkably low.