Efficacy of Mirtazapine for Prevention of Depressive Relapse: A Placebo-Controlled Double-Blind Trial of Recently Remitted High-Risk Patients
J Clin Psychiatry 2001;62:782-788
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: The necessity of antidepressant
continuation-phase therapy following acute-phase response has
resulted in the need to characterize the longer-term efficacy and
safety of all new medications. Previous studies using
"extension" protocols suggest that mirtazapine has
sustained antidepressant effects. The current study was performed
to evaluate the efficacy and safety of up to 1 year of
mirtazapine therapy, using a more rigorous, randomized,
placebo-controlled discontinuation design.
Method: An intent-to-treat sample of 410
patients meeting DSM-IV criteria for moderate-to-severe recurrent
or chronic major depressive episodes began 8 to 12 weeks of
open-label therapy with mirtazapine (flexibly titrated, 15-45
mg/day). Thereafter, 156 fully remitted patients (according to
Hamilton Rating Scale for Depression and Clinical Global
Impressions-Improvement scores) were randomly assigned to receive
40 weeks of double-blind continuation-phase therapy with either
mirtazapine or placebo.
Results: Mirtazapine therapy reduced the rate of
depressive relapse by more than half, with 43.8% of patients
relapsing on treatment with placebo as compared with 19.7% of the
mirtazapine-treated patients. The discontinuation rate due to
adverse events was 11.8% for active mirtazapine therapy versus
2.5% for placebo. Although weight gain was significantly greater
in the group receiving active medication during the double-blind
phase (p = .001), patients taking mirtazapine gained only 1.4 kg
(3.1 lb) across the 40 weeks of continuation therapy, and there
was no difference in the rates of weight gain as a new-onset
Conclusion: Continuation-phase therapy with
mirtazapine is effective and well tolerated.