Neuropsychiatric Disease and Treatment (May 2023)

Long-Term Treatment with Trazodone Once-A-Day (TzOAD) in Patients with MDD: An Observational, Prospective Study

  • Shrashimirova M,
  • Tyanev I,
  • Cubała WJ,
  • Wichniak A,
  • Vodickova-Borzova C,
  • Ruggieri A,
  • Bonelli A,
  • Lipone P,
  • Comandini A,
  • Cattaneo A

Journal volume & issue
Vol. Volume 19
pp. 1181 – 1193

Abstract

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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 [email protected]: 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%) reported an improvement on the CGI-I compared to baseline. Results of the study confirm the well-known safety and tolerability of TzOAD, as well as its effectiveness on depressive symptoms, such as improvement in QoL, sleep quality, and overall functioning accompanied by favourable adherence and low drop-out rate.Conclusion: To our knowledge, this is the first observational, long-term study in patients suffering from MDD, conducted with TzOAD. The improvement observed in clinical response, overall functioning, depressive symptoms, and QoL along the 24 weeks (+4) maintenance period and the very good retention rate, suggest that TzOAD may represent an effective and well tolerated treatment option for patients suffering from MDD.Keywords: major depressive disorder, trazodone, patient-reported outcome, real-world evidence, effectiveness, long-term follow-up

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