2 research outputs found

    Risk Perception among Psychiatric Patients during the COVID-19 Pandemic

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    The fear of the new coronavirus infection has driven many non-COVID-19 patients away from essential healthcare. Our study aimed to investigate the perception of risk and feelings of danger for the contagion in a sample of Italian psychiatric patients. We conducted a cross-sectional observational study during the second wave of the COVID-19 pandemic and the lockdown in Italy. The risk perception and risk-related variables were assessed in a sample of 150 consecutive patients with a previous diagnosis of major depression (50), bipolar I disorder (50), and schizophrenia seeking ambulatory care using a questionnaire previously administered to the general Italian population. Our results showed that patients were more concerned about economic, psychological, and interpersonal consequences of COVID-19 pandemic, rather than about their own health. At the multiple regression analysis, the likelihood of COVID-19 resolution was positively influenced by the diagnosis of schizophrenia, the increased perceived effectiveness, and the presence of positive emotions. Indeed, positive emotions and uncertainty positively influenced interpersonal risk. Our study highlights the need to provide more support to psychiatric patients during emergency events to prevent them from engaging in risky behaviors

    Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trialResearch in context

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    Summary: Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the “2016 Call for Independent Drug Research”
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