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A double‐blind randomized placebo‐controlled study of the efficacy and safety of pirlindole, a reversible monoamine oxidase A inhibitor, in the treatment of depression

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 ≤ 7, ≥8 and ≤15, 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.