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.

• Klíčová slova
• effectiveness, long-term follow-up, major depressive disorder, patient-reported outcome, real-world evidence, trazodone,
• Publikační typ
• časopisecké články MeSH

This 8-week study was designed to explore any correlation between a passive data collection approach using a wearable device (i.e., digital phenotyping), active data collection (patient's questionnaires), and a traditional clinical evaluation [Montgomery-Åsberg Depression Rating Scale (MADRS)] in patients with major depressive disorder (MDD) treated with trazodone once a day (OAD). Overall, 11 out of 30 planned patients were enrolled. Passive parameters measured by the wearable device included number of steps, distance walked, calories burned, and sleep quality. A relationship between the sleep score (derived from passively measured data) and MADRS score was observed, as was a relationship between data collected actively (assessing depression, sleep, anxiety, and warning signs) and MADRS score. Despite the limited sample size, the efficacy and safety results were consistent with those previously reported for trazodone. The small population in this study limits the conclusions that can be drawn about the correlation between the digital phenotyping approach and traditional clinical evaluation; however, the positive trends observed suggest the need to increase synergies among clinicians, patients, and researchers to overcome the cultural barriers toward implementation of digital tools in the clinical setting. This study is a step toward the use of digital data in monitoring symptoms of depression, and the preliminary data obtained encourage further investigations of a larger population of patients monitored over a longer period of time.

• Klíčová slova
• active data collection, digital phenotyping, major depressive disorder, mental health, passive data collection, trazodone,
• Publikační typ
• časopisecké články MeSH