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. 2023 May 12:19:1181-1193.
doi: 10.2147/NDT.S399948. eCollection 2023.

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

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 Cattaneo #  6
Affiliations

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

Milena Shrashimirova et al. Neuropsychiatr Dis Treat. .

Abstract

Purpose: 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: effectiveness; long-term follow-up; major depressive disorder; patient-reported outcome; real-world evidence; trazodone.

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Conflict of interest statement

Wiesław Jerzy Cubała has had grants from Acadia, Alkermes, Allergan, Angelini, Auspex Pharmaceuticals, BMS, Celon, Cephalon, Cortexyme, Ferrier, Forest Laboratories, GedeonRichter, GWPharmaceuticals, HMNC Brain Health, IntraCellular Therapies, Janssen, KCR, Lilly, Lundbeck, Minerva, MSD, NIH, Novartis, Orion, Otsuka, Perception Neuroscience, Sanofi, Servier. Wiesław Jerzy Cubała reports Honoraria from: Adamed, Angelini, AstraZeneca, BMS, Celon, GSK, Janssen, KRKA, Lekam, Lundbeck, Minerva, NeuroCog, Novartis, Orion, Pfizer, Polfa Tarchomin, Sanofi, Servier, Zentiva. Involvement in Advisory boards: Angelini, Celon (terminated), Douglas Pharmaceuticals, Janssen, MSD, Novartis, Sanofi. Adam Wichnaik has received research support from Angelini, Servier and Lekam; he has served on speakers’ bureaus for Adamed, Angelini, Biofarm, Egis, G.L. Pharma, Janssen, Krka, Lekam, Lundbeck, PolfaTarchomin, Sanofi, Servier; he has received personal feeds from Aflofarm, Bausch, Chiesi, Gedeon Richter, Polpharma, Stada; and he has served as a consultant for Adamed, Angelini, Elmiko, Janssen, Lekam, Lundbeck. Claudia Vodickova-Borzova reports grants from Clinical study, outside the submitted work. Alessandro Ruggieri, Paola Lipone, Alessandro Comandini, and Agnese Cattaneo are full-time employees of Angelini Pharma S.p.A. Annalisa Bonelli was a full-time employee of Angelini Pharma S.p.A. at the time of study conduction. Prof Ivan Tyanev declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Prof Milena Shrashimirova declare that they have no competing interests.

Figures

Figure 1
Figure 1
Disposition of patients.
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