title: The results of the Swiss observational study of the new, fast-dissolving mirtazapine formulation in depressed patients.
abstract: Objective. The purpose of the present study was to document the experience with the use of a new, fast-dissolving oral tablet (FDT, RemeronSolTab®) of mirtazapine, a NaSSA antidepressant, in the treatment of depressed patients in daily practice in Switzerland. Methods. It was an open, prospective collection of observations in a total of 1121 depressive patients (>18 years old, both sexes). The treatment duration was 8 weeks with assessments after the second and eighth week. Efficacy measures were CGI (seven points) and specific check-lists for the ratings of severity of anxiety and sleep disturbances. At the end of the trial the acceptance (eight-item questionnaire) of the new formulation was recorded too. Results. The results showed that there was highly significant (P<0.001) and rapid improvement of severity of depression, anxiety and sleep disturbances in the whole population. Subgroup analyses showed that the antidepressant efficacy was independent of gender, initial severity of depression or of the type of depression (first episode, recurrent, chronic depression). The majority of patients (80%) liked at least one of the properties of FDT and, out of 75% of patients having experience with conventional tablet, 50% stated to be better compliant with this new formulation. Conclusion. This report documents the antidepressant efficacy of mirtazapine FDT. The new formulation found good acceptance by the patients. The results also suggest a likelihood of improved compliance with the mirtazapine FDT.
authors.affiliation: ADI International Institute for Advancement of Drug Development, Basel, Switzerland.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Delini-Stula
authors.forename: Roland
authors.initials: R
authors.lastname: Bischof
keywords: Depression; NaSSA; antidepressants; clinical trials; mirtazapine; new formulations