OBJECTIVE: The aim of the study was to evaluate the efficacy, tolerability, and safety of once-a day trazodone tablets (Trittico Prolong® 300 mg) in patients with moderate to severe depression in routine clinical practice. METHODS: Men and women ≥18 years old with Montgomery-Åsberg Depression Rating Scale (MADRS) scores > 21 and Clinical Global Impression - Severity (CGI/S) ≥4 were included in this post-authorization, non-interventional, observational prospective safety study, conducted in 8 psychiatric centers in the Czech -Republic. The acute treatment phase lasted 5 weeks: 1 week of titration and 4 weeks of full-dose treatment. Patients had follow-up visits 9 and 21 weeks after commencing -treatment. RESULTS: Overall, 85 patients were enrolled in the study, of which 80 completed the acute treatment of 5 weeks. There were significant decreases in the overall MADRS score from the baseline mean value of 27.4-21.2 at week 1 (p < 0.001), and a further decrease to 7.9 at week 5 (p < 0.001). The severity of depression according to CGI/S gradually declined. Most patients reported improvement after 6 days of trazodone treatment. The most frequent adverse drug reactions (ADRs) reported were somnolence and fatigue. CONCLUSIONS: Trazodone, in the new extended-release formulation, had very good effects in clinical practice, both in previously untreated depressive episodes and in episodes not responsive to previous antidepressive therapy.

Central European Institute of Technology Masaryk University Brno Czech Republic Department of Psychiatry Faculty Hospital Brno Brno Czech Republic Department of Psychiatry University Hospital Ostrava Ostrava Czech Republic Department of Neurology and Psychiatry Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Medical Angelini Pharma Brno Czech Republic

Department of Psychology Faculty of Arts Masaryk University Brno Czech Republic

Institute of Biostatistics and Analyses Brno Brno Czech Republic

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