A Double-Blind, Randomized, Group-Comparative Study of the Tolerability and Efficacy of 6 Weeks’ Treatment With Mirtazapine or Fluoxetine in Depressed Chinese Patients
J Clin Psychiatry 2003;64(8):921-926
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Aim: To compare the efficacy and tolerability of
mirtazapine and fluoxetine treatment in a sample population
consisting of Chinese patients suffering moderate-to-severe
Method: 133 patients with a diagnosis of major
depressive episode (DSM-IV) and scoring 15 or more on the 17-item
Hamilton Rating Scale for Depression (HAM-D) were randomly
assigned to receive 6 weeks of treatment with either mirtazapine
(15-45 mg/day) or fluoxetine (20-40 mg/day). Efficacy was
assessed using the HAM-D and Clinical Global Impressions scale,
with analyses performed on the intent-to-treat sample using the
last-observation-carried-forward method. Safety analysis was
based on the all-subjects-treated group.
Results: Mean daily doses were 34.1 mg for
mirtazapine (N = 66) and 30.7 mg for fluoxetine (N = 66). Thirty
patients in the mirtazapine group and 22 in the fluoxetine group
dropped out. Both drugs proved equally effective for reduction of
the overall symptoms of depression throughout the treatment
period. At day 42, the mean reductions in HAM-D total score
(compared with baseline) were 11.8 and 10.6 for the mirtazapine
and fluoxetine groups, respectively; however, the changes were
not statistically significant. Both treatments were well
tolerated, with more nausea and influenza-like symptoms observed
for the fluoxetine group, and greater weight increase and
somnolence for the mirtazapine analog.
Conclusion: Both mirtazapine and fluoxetine were
indistinguishable in effectiveness for treatment of depressive
symptoms, and both were well tolerated by our population of
depressed Chinese patients. In line with analogous Western
reports, the safety of mirtazapine and fluoxetine was comparable
for our depressed Chinese patients; however, slightly different
side effect profiles were noted for the 2 drugs in our study.