Duloxetine and Paroxetine in the Treatment of Major Depressive Disorder: Report on a Clinical Trial

摘要

Objective: To evaluate the efficacy and safety of enteric-coated duloxetine tablets for patients with depressive disorders. Methods: A double-blind, double-dummy, parallel-randomized controlled study was carried out for 51 patients who met the DSM-Ⅳ criteria of depression and depressed episodes. Twenty-five were treated with duloxetine (40 ~ 60 mg?d-1) and the rest with paroxetine (20mg?d-1) for 8 weeks. Efficacy was then assessed using: the Hamilton Depression Rating Scale (HAMD); the Hamilton Anxiety Scale (HAMA); the Montgomery Depression Rating Scale (MADRS); the Sheehan Disability Scale (SDS); the visual analogue scale (VAS-PI) and the Clinical Global Impression (CGI). Safety assessments included physical examinations, laboratory evaluations, and electrocardiographic findings of adverse events. Assessment time points were evaluated at the baseline and at 1, 2, 4, 6 and 8 weeks after starting treatment. Results: After 8 weeks of treatment, the total effective rates of duloxetine group and paroxetine group were 72.0 % and 73.1 % respectively, with no significant difference (t = 0.465, p = 0.612). Clinical cure rates for the duloxetine group and paroxetine group were 20.0 % and 23.1 % respectively, with no significant difference (t = 0.547, p = 0.590). The HAMD17, HAMA, MADRS, SDS, VAS-PI and CGI scores for both groups decreased significantly, with a statistical difference between the baseline and other time points (p p 0.05). The main adverse events of two groups were dry mouth, nausea, dizziness, and stomach discomfort. Conclusions: Enteric-coated duloxetine tablet is an effective antidepressant with fewer side effects, better safety, and is more suitable for the treatment of depression patients.