Mirtazapine: Efficacy and Tolerability in Comparison With Fluoxetine in Patients With Moderate to Severe Major Depressive Disorder

摘要: Objective: To compare the efficacy and tolerability of mirtazapine fluoxetine in depressed inpatients outpatients. Method: Patients with a major depressive episode (DSM-III-R), baseline score ≥ 21 on 17-item Hamilton Rating Scale for Depression (HAM-D), ≥2 HAM-D Item 1 (depressed mood) were randomly assigned to 6-week treatment either (N = 66, 15-60 mg/day) or 67, 20-40 mg/day). The upper limit dose range was above approved United States (15-45 Efficacy evaluated by HAM-D, Clinical Global Impressions, Visual Analogue Mood (VAMRS), Quality Life Enjoyment Satisfaction Questionnaire (QLESQ). analyses performed intent-to-treat group using last-observation-carried-forward method. Results: Mean total scores at 26.0 mirtazapine- 26.1 fluoxetine-treated group. decrease from larger than throughout period, reaching statistical significance days 28. At assessments day onward, absolute difference between 2 study groups favoring ranged 3.7 4.2 points, magnitude usually seen an efficacious antidepressant drug placebo. dosages weeks 1-4 36.5 mg/day 19.6 fluoxetine; respective 5-6 56.3 mg 35.8 mg. Similar numbers patients dropped out due adverse events; profiles comparable except changes body weight which statistically significantly more pronounced compared Conclusion: We found that as well tolerated effective after 3 4 therapy.