Abstract T P121: A Comparative Study of Duloxetine and Paroxetine in Japanese Patients With Post-Stroke Depression

Abstract

Background and methods: Patients with stroke may suffer from post-stroke depression and concomitant pain symptoms. A double-blind, parallel-group, controlled study was performed to investigate if duloxetine was superior to paroxetine in terms of improvement in symptoms of depression and pain in Japanese patients with post-stroke depression in a fixed-dose design. The efficacy and safety of duloxetine 60 mg/day were also assessed in comparison with those at the standard dose of 40 mg/day. Results: Changes in 17-item Hamilton depression rating scale (HAM-D) total score (mean ± standard deviation) for group D1 (duloxetine 40 mg/day), group M2 (duloxetine 60 mg/day), and group PX (paroxetine 20 mg/day) were –14.9 ± 5.6, –15.6 ± 6.4, and –11.4 ± 6.2, respectively, and the estimated differences in total score for group PX (Dunnett’s 95% simultaneous confidence interval) were 3.8 (3.2 to 4.4) for group D1 and 4.2 (3.6 to 4.8) for group D2. The superiority of groups M1 and M2 to group PX was thus confirmed, because the upper confidence limit of differences between groups D1 and PX and between groups D2 and PX was more than 3.2. The groups M1 and M2 presented a reduction in the pain, which was not observed in the group PX. The incidence of treatment-related adverse events was 21% for group D1, 28% for group D2, and 30% for group PX, indicating no significant difference between the three groups. Conclusion: These results demonstrate that duloxetine 40 mg/day and 60 mg/day is superior to paroxetine in terms of efficacy on post-stroke depression and central pain.