Remeron Clinical Trials and Studies
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Remeron Clinical Trials and Studies
The efficacy of Remeron (mirtazapine) Tablets as a treatment for depression was established in four placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depression. Patients were titrated with Remeron (mirtazapine) from a dose range of 5 mg up to 35 mg/day. Overall, these studies demonstrated mirtazapine to be superior to placebo on at least three of the following four measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Superiority of mirtazapine over placebo was also found for certain factors of the HDRS, including anxiety/somatization factor and sleep disturbance factor. The mean Remeron (mirtazapine) dose for patients who completed these four studies ranged from 21 to 32 mg/day. A fifth study of similar design utilized a higher dose (up to 50 mg) per day and also showed effectiveness.
Examination of age and gender subsets of the population did not reveal any differential responsiveness on the basis of these subgroupings.
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