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Psychedelics are a group of psychoactive substances which produce complex and subjective changes to consciousness and carry unique safety considerations. There is a growing body of work investigating the use of psychedelics for mental health treatment alongside increasing socio-cultural and political acceptance. This rapid evolution has prompted corporations to fund psychedelic clinical trials, leading to a potential rise in conflicts of interest in relevant studies and publications. However, the body of evidence for the safety and efficacy of psychedelic-assisted psychotherapy for psychiatric illnesses is early. There is concern regarding the introduction of bias in psychedelic clinical trials and the selective reporting of results amidst and beyond corporate involvement. At a crucial time in psychedelic drug reform, this paper explores the safety concerns associated with psychedelics, the potential influences of financial stakeholders on safety outcome reporting and the importance of balanced science communication in maintaining public health and safety., Competing Interests: MS has received honoraria/has been a consultant for Angelini, AbbVie, Lundbeck, Otsuka. No other conflicts of interest declared concerning the publication of this article.

Objective: To evaluate the direct, indirect, and total prospective effects of serum concentrations of [25(OH)D, 25-hydroxycolecalciferol] on depressive symptoms in older adults., Methods: Data from the second (2013-2015) and third (2017-2019) waves of the EpiFloripa Aging Cohort Study (≥ 60 years) were analyzed. Depressive symptoms were assessed by the 15-item Geriatric Depression Scale (GDS-15). 25(OH)D levels were measured using the microparticle chemiluminescence method. A directed acyclic graph (DAG) was constructed to identify the minimum set of adjustments. Structural equation modeling (SEM) analysis was used to determine the effects of 25(OH)D on depressive symptoms., Results: A total of 574 older adults' data were analyzed (63.1% female). In the follow-up (n=390), 16.2% of older adults presented high-severity of depressive symptoms (> or = 6 points). SEM analysis revealed a small direct and negative effect of 25(OH)D (β=-0.11, P < 0.05), and a total negative effect (β=-0.13; P < 0.05) on depressive symptoms on wave 3 (an increase of 25(OH)D led to a decrease on depressive symptoms). No direct effect on wave 2 and no indirect effect mediated by depressive symptoms in wave 2 were found., Conclusions: Findings indicate a prospective association between 25(OH)D and depressive symptoms, suggesting a long-term effect in older adults from southern Brazil.