DOUBLE-BLIND-STUDY OF MIRTAZAPINE AND PLACEBO IN HOSPITALIZED-PATIENTS WITH MAJOR DEPRESSION

The purpose of the present 6-week multicenter dose finding study was t o compare the efficacy and tolerability of mirtazapine (preferentially presynaptic alpha(2)-adrenergic receptor blocker) to placebo in hospi talized patients with major depression. The clinical efficacy was eval uated with the Hamilton Depression Scale (HAM-D), Montgomery-Asberg De pression Rating Scale (MADRS), Beck Self-Rating Depression Scale, Glob al Assessment Scale (GAS), and Brief Psychiatric Rating Scale (BPRS). The side effects were recorded on a checklist of emergent symptoms (RO SE) and physical examinations, ECG, clinical chemistry, and hematology tests were carried out. The dosages of mirtazapine were gradually rai sed from 15 mg to 50 mg. One hundred and fourteen patients were includ ed. Twenty-two patients (37%) in the mirtazapine group and 24 (44%) in the placebo group were prematurely withdrawn from the study mainly du e to inadequate efficacy. The decrease in HAM-D and MADRS was generall y more pronounced in the mirtazapine group than in the placebo group. Minor side effects were reported in less than 15% of the patients in b oth groups. Only fatigue and faintness were slightly more pronounced i n the mirtazapine group than in the placebo group. No significant chan ges were found in laboratory parameters. Because of methodological fla ws like combining a dose finding study with a placebo controlled study , further conclusions should not be made on the efficacy of mirtazapin e when treating depressive patients.