Shrashimirova Milena, Tyanev Ivan, Cubała Wiesław J, Wichniak Adam, Vodickova-Borzova Claudia, Ruggieri Alessandro, Bonelli Annalisa, Lipone Paola, Comandini Alessandro, Cattaneo Agnese
Diagnostic Consultative Center 14, Hospital VITA, Sofia, Bulgaria.
Multiprofile Hospital for Active Treatment, Medical Clinic, Targovishte, Bulgaria.
Neuropsychiatr Dis Treat. 2023 May 12;19:1181-1193. doi: 10.2147/NDT.S399948. eCollection 2023.
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.
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.
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.
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.
这是一项观察性、前瞻性、单组、多中心国际研究，旨在描述重度抑郁症（MDD）患者接受曲唑酮一日一次（TzOAD）单药治疗24周期间的临床反应、功能损害和生活质量（QoL）。
从3个欧洲国家（保加利亚、捷克共和国和波兰）的26个地点招募了总共200例诊断为MDD且接受过TzOAD单药治疗的患者，包括精神科私人诊所、综合医院和精神科医院的门诊部门。研究评估由医生和患者在常规护理实践中的常规就诊期间完成。
通过24（±4）周时临床总体印象改善量表（CGI-I）反应者百分比评估临床反应。与基线相比，大多数患者（86.5%）报告CGI-I有所改善。研究结果证实了TzOAD众所周知的安全性和耐受性，以及其对抑郁症状的有效性，如生活质量、睡眠质量和整体功能的改善，同时伴有良好的依从性和低脱落率。
据我们所知，这是第一项对MDD患者进行的使用TzOAD的观察性长期研究。在24周（+4）维持期观察到的临床反应、整体功能、抑郁症状和生活质量的改善以及非常好的保留率，表明TzOAD可能是MDD患者一种有效且耐受性良好的治疗选择。
