A DOUBLE-BLIND-STUDY COMPARING PAROXETINE AND MAPROTILINE IN DEPRESSED OUTPATIENTS

A double-blind multicenter randomized parallel group study comparing p aroxetine and maprotiline was carried out in a total of 544 outpatient s. Included were patients with varying degrees of severity of depressi ve symptoms who fulfilled modified RDC criteria for either Minor or Ma jor Depression and showed a HAMD-17 score of greater than or equal to 13. No concomitant benzodiazepine treatment was allowed. Duration of t reatment was 6 weeks, after an initial wash-out period. Doses were fix ed during the first 3 weeks of treatment, patients receiving either 20 mg paroxetine or 100 mg maprotiline daily. An option for dose escalat ion was provided for insufficient responders after 3 weeks. The weekly assessments comprised rating of the HAMD-17, MADRS, BRMS, RDS, HAMA, GAS, and CGI scales and registration of adverse events by non-leading questions. An intention-to-treat and a completer analysis were perform ed. Response was defined as a HAMD-17 reduction of greater than or equ al to 50% or a HAMD-17 score of less than or equal to 9 at the end of the study or at dropout. The treatment groups were comparable accordin g to demographic data. Overall evaluation indicated equieffective and good antidepressant and anxiety-reducing properties for paroxetine and maprotiline. No persistent significant differences between treatment groups were observed on any assessment instrument. There was no differ ence in the frequency of observed side-effects, but side-effect profil es were markedly different, as maprotiline patients had more anticholi nergic and paroxetine patients more SSRI-typical side-effects.