Mirtazapine: Efficacy and Tolerability in Comparison With Fluoxetine in Patients With Moderate to Severe Major Depressive Disorder
J Clin Psychiatry 1998;59(6):306-312
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Objective: To compare the efficacy and
tolerability of mirtazapine and fluoxetine in depressed
inpatients and outpatients.
Method: Patients with a major depressive episode
(DSM-III-R), a baseline score of ž21 on the 17-item Hamilton
Rating Scale for Depression (HAM-D), and ž2 on HAM-D Item 1
(depressed mood) were randomly assigned to a 6-week treatment
with either mirtazapine (N=66, 15-60 mg/day) or fluoxetine (N=67,
20-40 mg/day). The upper limit of the mirtazapine dose range was
above the dose range approved in the United States (15-45
mg/day). Efficacy was evaluated by the HAM-D, Clinical Global
Impressions, the Visual Analogue Mood Rating Scale (VAMRS), and
the Quality of Life Enjoyment and Satisfaction Questionnaire
(QLESQ). The efficacy analyses were performed on the
intent-to-treat group using the last-observation-carried-forward
Results: Mean total 17-item HAM-D scores at
baseline were 26.0 for the mirtazapine- and 26.1 for the
fluoxetine-treated group. The decrease from baseline on the HAM-D
was larger in the mirtazapine than in the fluoxetine group
throughout the treatment period, reaching statistical
significance at days 21 and 28. At assessments from day 21 and
onward, the absolute difference between the 2 study groups
favoring mirtazapine ranged from 3.7 to 4.2 points, the magnitude
of difference usually seen between an efficacious antidepressant
drug and placebo. Mean dosages at weeks 1-4 were 36.5 mg/day for
mirtazapine and 19.6 mg/day for fluoxetine; the respective
dosages at weeks 5-6 were 56.3 mg and 35.8 mg. Similar numbers of
patients dropped out due to adverse events; tolerability profiles
were comparable except for changes in body weight from baseline
which were statistically significantly more pronounced in the
mirtazapine group compared to the fluoxetine group.
Conclusion: We found that mirtazapine was as
well tolerated as fluoxetine and significantly more effective
after 3 and 4 weeks of therapy.