Efficacy and Safety of Mirtazapine in Major Depressive Disorder Patients After SSRI Treatment Failure: An Open-Label Trial
J Clin Psychiatry 2001;62(6):413-420
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Objective: To evaluate the efficacy and safety
of mirtazapine in depressed outpatients who have shown
nonresponse or intolerance to selective serotonin reuptake
inhibitor (SSRI) therapy.
Method: In this open-label, 8-week study, the
efficacy and safety of mirtazapine among 103 outpatients with
DSM-IV major depressive disorder who had failed previous therapy
with an SSRI (fluoxetine, paroxetine, or sertraline) were
evaluated. The primary efficacy measure was the 17-item Hamilton
Rating Scale for Depression (HAM-D-17), and safety assessments
included reported adverse events, routine laboratory assessments,
physical examinations, and assessments of vital signs. A 4-day
washout period followed by mirtazapine treatment was compared
with an immediate switch from the SSRI to mirtazapine.
Results: Based on mean HAM-D-17 scores at
endpoint and response rates of 48% based on the criterion of
>= 50% reduction in HAM-D-17 score, mirtazapine was found to
be an effective treatment for a substantial proportion of
patients for whom an SSRI was ineffective and/or poorly
tolerated. Mirtazapine was well tolerated, with sedation and
appetite increase/weight gain the most commonly reported adverse
events. In addition, no difference in efficacy, safety, or
tolerability was observed for patients undergoing an immediate
switch from an SSRI (after having been tapered to the minimal
effective dose) to mirtazapine, compared with those undergoing
the imposition of a 4-day drug-free washout.
Conclusion: In this clinical trial with depressed, hypogonadal men, antidepressant effects of testosterone replacement could not be differentiated from those of placebo.