Pirlindole: Results of an Open Clinical Study in Out-Patients and of a Double-Blind Study Against Maprotiline

Summary

After the antidepressant pirlindole administered at the dosage of 225 mg/day had been shown to have a very good antidepressive efficacy in a 21-day open clinical trial in 37 outpatients with endogenous or neurotic depression, pirlindole was tested against the reference substance maprotiline in a randomised double-blind study in 40 out-patients. The equitherapeutic dosage was 225 mg of pirlindole and 150 mg of maprotiline, divided into 3 single doses each. The patients were suffering from either endogenous, neurotic, or exhaustion depression. On the basis of the initial findings obtained by means of the SPA and HAMD scales, the results of this study show a very good improvement of depressive symptomatology under medication in both treatment groups. This applies to both overall scores and to individual characteristics (symptoms). Analysis of the overall scores of either scale shows a comparable relief of symptoms during the course of therapy.

Similarly, the side effects observed during the treatment period did not reveal any difference between the two drugs, neither with regard to their incidence nor with regard to their weighting. Disturbances of accomodation occurred with maprotiline only (3 observations on day 7 and 1 observation on day 14). Dryness of the mouth occurred equally often in either treatment group (16 times), but it was with maprotiline only that therapy has to be discontinued in two cases (day 7 and day 14, resp.). Transitory side effects were observed with both drugs - mostly on day 7; those were mainly dryness of the mouth and sweating with pirlindole. These phenomena disappeared during the further course of treatment. There were 7 discontinuations of therapy in the maprotiline group and 5 in the pirlindole group, whereby 1 discontinuation in either grop was due to very good improvement.