Moclobemide, imipramine, and placebo in the treatment of major depression (DSM III).

Seventy five patients, diagnosed according to the Structured Clinical Interview for DMS III ("unipolar", Major depression, single or recurrent, with or without melancholia) were treated, in a double-blind fashion, with either moclobemide, imipramine or placebo, during six weeks. The three treatment groups were homogeneous as far as demographic and clinical characteristics were concerned. Patients were in their forties, predominantly females and with long lasting (more than six months) episodes of moderate or severe depressions. From day seven onwards most patients took moclobemide 600 mg/d, imipramine 200 mg/d or 6 caps/d of placebo; only two cases took lower dosages due to intolerance. There were eleven drop-outs, evenly scattered among the three groups. Outcome assessed by means of the Hamilton Scale for Depression and Global Efficacy Evaluations showed a very significant superiority of the two active drugs over placebo. The efficacy of the two drugs was comparable. Side effects were significantly more frequent and more severe in the imipramine group. The tolerability of moclobemide was similar to placebo. These findings are discussed in relation to methodological issues. They point to the conclusion, that moclobemide may be the true "second generation antidepressant", comparably efficacious to the traditional compounds, producing far less side-effects, and because it is reversible, not requiring dietary or drug restrictions in clinical practice.