[Results of a clinical trial of levoprotiline]

The authors submit results of a double blind clinical trial of levoprotiline controlled by maprotiline. In the multicentre study (which is processed and interpreted in stages) participated after written informed consent 58 patients with the diagnosis of a major depressive disorder. During the first three weeks the results of levoprotiline and maprotiline (from 26 patients each) were processed. The trial lasted 42 days. The psychopathology of the patients was evaluated by independent blind raters by means of Montgomery and Asberg's scale (MADRS), Hamilton's scale for depression (HRDS) and general clinical impression (CGI). In all patients also the pharmacological and EEG response was assessed. In comparison to maprotiline, levoprotiline was clinically ineffective. Its plasma levels (40 ng/ml) were one third to one half of the values obtained with maprotiline in the same daily dosage (150 mg). Although levoprotiline has an EEG profile typical for classical thymoleptics, its clinical antidepressive action is negligible.