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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.

Objective: To identify sick leave days (SLD) predictors after starting antidepressant (AD) treatment in patients affected by major depressive disorder (MDD), managed by general practitioners, with a focus on different AD therapeutic approaches. Methods: Retrospective study on German IQVIA V R Disease Analyser database. 19-64 year old MDD patients initiating AD treatment between July-2016 and June-2018 were grouped by therapeutic approach (AD monotherapy versus combination/switch/add-on). Data were analysed descriptively by AD therapeutic approach, while a zero-inflated Poisson (ZIP) multiple regression model was run to evaluate SLD predictors. Results: 8,891 patients met inclusion criteria (monotherapy: 66%; combination/switch/add-on: 34%). All covariates had an influence on SLD after AD treatment initiation. Focussing on variables that physicians may more easily intervene to improve outcomes, it was found that the expected SLD number of combination/switch/add-on patients was 1.6 times that of monotherapy patients, and the expected SLD number of patients diagnosed with MDD before the decision to start AD treatment was 1.2 times that of patients not diagnosed with MDD. Conclusions: A patient tailored approach in the selection of AD treatment at the time of MDD diagnosis may improve functional recovery and help to reduce the socio-economic burden of the disease. KEY POINTSFew studies previously investigated the effect of antidepressant treatment approaches on sick leave days in major depressive disorder. To the authors' knowledge, this is the first study evaluating the effect of different antidepressant treatment approaches on sick leave days in major depressive disorder in German patients. Patients receiving antidepressant monotherapy treatment seemed to lose fewer working days than patients receiving antidepressants combination/switch/add-on therapy, both before and after starting treatment, even if differences were more pronounced after treatment has started. The use of antidepressant monotherapy or combination/switch/add-on therapy was the strongest predictor of sick leave days after starting antidepressant treatment: the expected number of sick leave days for the combination/switch/add-on group was 1.6 times that of the monotherapy group. Among factors associated with increased sick leave days, antidepressant therapeutic approach and the promptness of starting the antidepressant treatment when major depressive disorder is diagnosed, are those on which physicians may more easily intervene to improve outcomes. Findings from the present study suggest that a patient tailored approach may improve functional recovery and help reducing the socio-economic burden of the disease.

Background and objective: Foods for Special Medical Purposes (FSMPs) are formulated to support the nutritional needs of subjects with impaired capacity to ingest, digest or absorb ordinary food or nutrients. Polglumyt® is a proprietary highly purified, high quality glycogen obtained from mussels. Here we report the results of a single-center, single dose, open label, single arm study carried out to investigate acceptance (i.e. gastrointestinal tolerance and palatability), metabolic profile and safety of a low osmolarity, high-density energy Polglumyt®-based drink (the investigational product, IP) as a novel FSMP. Methods: Twelve healthy subjects received a single oral administration of the IP under fasting conditions. The study endpoints were: changes in gastrointestinal system tolerability at 3 h, 6 h and 24 h after IP intake; IP palatability evaluation; metabolic evaluation through the kinetic profile of circulating glucose, insulin and C-peptide from 0 h to 6 h after IP intake and changes from baseline in circulating triglycerides at 3 h and 6 h after IP intake. Results: The IP showed a good gastrointestinal tolerability and an acceptable palatability. The IP did not affect the physiological glycemic profile and the triglycerides levels 6 h after the intake. The IP was well tolerated by study subjects, with no or minor adverse events. Conclusions: The study results encourage additional clinical investigations on the IP as a novel FSMP in patients with impaired digestion or gastrointestinal absorption, unable to assume an ordinary diet, e.g. patients undergoing invasive gastrointestinal surgery, elderly or oncological patients, even with certain metabolic disorders.

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