Fluoxetine in early poststroke depression - A double-blind placebo-controlled study

Background and Purpose-Early poststroke depression (PSD) is a frequent and specific entity that impairs the rehabilitation and functional recovery of hemiplegic patients. This trial was designed to study the efficacy and tole rance of fluoxetine (FLX) in the treatment of early PSD. Methods-This was a multicenter, double-blind, placebo-controlled study. Rec ent hemiplegic patients (<3 months) suffering from major depressive disorde r (determined by International Classification of Diseases, 10th Revision, a nd Montgomery-Asberg Depression Rating Scale [MADRS] >19) were randomized t o receive either 20 mg/d fluoxetine (FLX) or placebo for 6 weeks. Patients were evaluated by use of the Motricity Index, Mini-Mental State Examination , Functional Independence Measure, and MADRS. Statistical analysis was perf ormed by using an intent-to-treat approach comparing the 2 groups at day 0 (baseline) and days 15, 30, and 45 tend point). Results-Of 121 patients screened, 31 were included in the study, 16 in the FLX group and 15 in the placebo group. There were no significant difference s in baseline characteristics among the 2 groups. The FLX-treated patients compared with placebo-treated patients demonstrated significant improvement in mean MADRS scores at end point (11.8+/-6.7 [mean+/-SD] versus 18.7+/-10 .0, respectively; P=0.05). FLX-treated patients compared with placebo-treat ed patients also demonstrated greater response rate (62.5% versus 33.3%, re spectively) and greater mean decrease of MADRS (16.6 versus 8.4, respective ly; P=0.02). There were no differences in motor, cognitive, or functional i mprovement and no significant side effects after FLX treatment, except for a patient with a moderate and transient increase of transaminases. Conclusions-FLX is an efficacious and well-tolerated treatment for early PS D. Further research is needed to evaluate the efficacy and safety of long-t erm treatment in this population.