DOUBLE-BLIND RANDOMIZED CONTROLLED PILOT-STUDY OF THE EFFICACY AND TOLERABILITY OF PIRLINDOLE, A REVERSIBLE INHIBITOR OF MONOAMINE-OXIDASE-A, AND MIANSERIN, IN THE TREATMENT OF DEPRESSION

This double-blind randomized pilot study aimed to compare the efficacy and the tolerability of pirlindole (150-225 mg/day), a reversible inh ibitor of monoamine oxidase A, and mianserin (60-90 mg/day) in the tre atment of major depression. Forty patients were included in the trial (20 pirlindole and 20 mianserin) and 38 patients (18 pirlindole and 20 mianserin) completed the whole study (28 days of administration). Bot h treatments exhibited highly significant improvements in the Hamilton Depression Rating Scale score (HDRS), the Hamilton Anxiety Rating Sca le score (HARS) and the Beck auto-evaluation scale score (BECK) from d ay 7 up to day 28. The evolution of the HDRS score in the two groups d id not differ significantly. The evolution of the HARS and BECK scores taken separately and the evolution of the combined total score (HDRS + HARS + BECK) significantly differed between the two groups, pirlindo le producing a significantly higher decrease than mianserin in the two separate scores on day 28 and on days 21 and 28 in the case of the co mbined total score. Two patients experienced adverse reactions, one in the pirlindole group complained of sleep disturbances and one in the mianserin group suffered from dry mouth. The results of this study att est to the efficacy and tolerability of pirlindole in the treatment of depression.