Cognitive, behavioral, and psychological manifestations of COVID-19 in post-acute rehabilitation setting: preliminary data of an observational study.

Psychological, emotional, and behavioral domains could be altered in COVID-19 patients and measurement of variables within these domains seems to be mandatory. Neuropsychological assessment could detect possible cognitive impairment caused by COVID-19 and the choice of appropriate tools is an important question. Aim of this exploratory study was to verify the effectiveness of an assessment model for patients with COVID-19. Twelve patients were enrolled and tested with Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Anxiety and Depression Short Scale (AD-R), and the Neuropsychiatry Inventory (NPI), at the time of their entrance (T0) and discharge (T1) from a rehabilitative unit. Moreover, a follow-up evaluation after 3 months (T2) has been conducted on eight patients. Results showed that at baseline (T0), 58.3% of the patients reported a score below cut-off at MMSE and 50% at MoCA. Although a significant amelioration was found only in NPI scores, a qualitative improvement has been detected at all tests, except for MoCA scores, in the T0-T1 trend analysis. A one-way repeated measures analysis of variance showed a significant variation in AD-R depression score, considering the three-assessment time (T0, T1, and T2). The evaluation and tracking over time of the impact of COVID-19 on cognitive, psychological, and behavioral domains has relevant implications for rehabilitation and long-term assistance needs planning. The choice of assessment tools should consider patients vulnerability and match the best compromise among briefness, sensitivity, and specificity.

Clinical validation of a combinatorial PharmAcogeNomic approach in major Depressive disorder: an Observational prospective RAndomized, participant and rater-blinded, controlled trial (PANDORA trial).

BACKGROUND: Major depressive disorder (MDD) is a common, chronic, debilitating mood disorder that causes serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line treatment option; however, only approximately one third of patients respond to the first treatment because of the ineffectiveness or side effects of antidepressants. Precision medicine in psychiatry might offer clinicians the possibility to tailor treatment according to the best possible evidence of efficacy and tolerability for each subject. In this context, our study aims to carry out a clinical validation of a combinatorial pharmacogenomics (PGx) test in an Italian MDD patient cohort with advocacy license independence. METHODS: Our study is a prospective participant- and rater-blinded, randomized, controlled clinical observational trial enrolling 300 MDD patients who are referred to psychiatric services to receive a new antidepressant due to the failure of their current treatment and/or the onset of adverse effects. Eligible participants are randomized to the TGTG group (Treated with Genetic Test Guide) or TAU group (Treated as Usual). For all subjects, DNA is collected with a buccal brush. The primary outcome is the reduction in depressive symptomatology. The secondary outcomes involve a range of scales that assess MDD symptoms and social functioning outcomes. The assessment is performed at four timepoints: baseline and 4, 8, and 12 weeks. DISCUSSION: This project represents the first randomized controlled clinical trial to investigate whether a non-commercial PGx test improves outcomes in an MDD naturalistic cohort. Moreover, the identification of new genetic variants associated with non-response or side effects will improve the efficacy of the test, leading to further cost-saving. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04615234. Registered on November 4, 2020.