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Milena Shrashimirova,1,* Ivan Tyanev,2,* Wiesław J Cubała,3,* Adam Wichniak,4,* Claudia Vodickova-Borzova,5,* Alessandro Ruggieri,6,* Annalisa Bonelli,6,* Paola Lipone,6,* Alessandro Comandini,6,* Agnese Cattaneo6,* 1Diagnostic Consultative Center 14, Hospital VITA, Sofia, Bulgaria; 2Multiprofile Hospital for Active Treatment, Medical Clinic, Targovishte, Bulgaria; 3Department of Psychiatry, Medical University of Gdańsk, Gdańsk, Poland; 4Third Department of Psychiatry and Sleep Disorders Center, Institute of Psychiatry and Neurology, Warsaw, Poland; 5Psychiatry and Neurology, Brain-Soultherapy.s.r.o, Kladno, Czech Republic; 6Global Medical Department, Angelini Pharma S.p.A, Rome, Italy*These authors contributed equally to this workCorrespondence: Alessandro Ruggieri, Global Medical Department, Angelini Pharma S.p.A, Viale Amelia 70, Rome, 00181, Italy, Tel +390691045309, Email alessandro.ruggieri@angelinipharma.comPurpose: This was an observational, prospective, single-group, multicentre, international study aimed to describe the clinical response, functional impairment, and quality of life (QoL) of patients suffering from major depressive disorder (MDD) and in treatment with Trazodone Once-A-Day (TzOAD) monotherapy, over a 24-week period.Patients and Methods: A total of 200 patients with a diagnosis of MDD who had been treated with TzOAD monotherapy were enrolled from 26 sites across 3 European countries (Bulgaria, Czech Republic, and Poland), including psychiatric private practices, and outpatient departments from general and psychiatric hospitals. Study assessments were completed by physicians and patients during routine visits within the normal practice of care.Results: Clinical response was assessed by Clinical Global Impressions – Improvement (CGI-I) responders’ percentage at 24 (± 4) weeks. The majority of patients (86.5%) r