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The efficacy and safety of pirlindole (300 mg/day), a new reversible inhibitor of monoamine oxidase A, have been evaluated in a multicentre placebo-controlled double-blind randomized trial in 103 in-patients suffering from unipolar major depression (DSM-III-R 296.2, 296.3) over a 42-day period after a run-in placebo period of 6 days. Pirlindole produced a significantly greater decrease than placebo in the Hamilton depression score (from day 28), the Hamilton anxiety score (from day 28) and the Montgomery-Asberg depression score (on day 42). On day 42, the Hamilton depression score was < or = 7, > or = 8 and < or = 15, or > or = 16 in 21%, 45% and 34%, respectively, in the placebo group compared to 72%, 24% and 3.4%, respectively, in the pirlindole group (P < 0.001). The differences between the two groups in terms of tolerance and safety were not statistically significant.

The aim of this double-blind randomized study was to compare the efficacy and the tolerability of moclobemide (300-600 mg daily) and pirlindole (150-300 mg daily), two reversible inhibitors of MAO-A (RIMAs), in the treatment of depression. In total 116 patients were included in the trial, 111 patients (52 patients on pirlindole and 59 patients on moclobemide) were evaluable for efficacy and safety, and 77 patients completed the whole study (42 days of administration). Both treatments produced highly significant improvements in the Hamilton Depression Rating Scale (HDRS) score, the Hamilton Anxiety Rating Scale (HARS) score and the Montgomery-Asberg Rating Scale (MADRS) score from day 7 to day 42. The pattern of development of the three scores in the two groups did not differ significantly. After 42 days of treatment, an improvement of > or = 50% in the HDRS score was noted in 80% and 67% of patients in the pirlindole and moclobemide groups, respectively. A total of 30 (58%) patients on pirlindole and 33 (56%) patients on moclobemide experienced side-effects that were considered to be possibly or probably related to the medication. The differences between the two drugs were non-significant for all types of side-effect, with the exception of dry mouth and tachycardia, which were significantly more frequent with moclobemide.