Search

Background: To date, few randomized controlled trials of psilocybin with non-directive support exist for obsessive-compulsive disorder (OCD). Results and participant feedback from an interim analysis of an ongoing single-dose trial (NCT03356483) converged on the possibility of administering a higher fixed dose and/or more doses of psilocybin in future trials for presumably greater benefits., Objectives: This trial aims to evaluate the safety, feasibility, tolerability, and clinical effects of two doses of psilocybin paired with non-directive support in the treatment of OCD. This trial also seeks to examine whether two doses of psilocybin lead to greater OCD symptom reduction than a single dose, and to elucidate psychological mechanisms underlying the effects of psilocybin on OCD., Design: A randomized (1:1), waitlist-controlled design with blinded ratings will be used to examine the effects of two doses of oral psilocybin paired with non-directive support vs. waitlist control on OCD symptoms. An adaptive dose selection strategy will be implemented (i.e., first dose: 25 mg; second dose: 25 or 30 mg)., Methods and Analysis: This single-site trial will enroll 30 adult participants with treatment-refractory OCD. Aside from safety, feasibility, and tolerability metrics, primary outcomes include OCD symptoms assessed on the Yale-Brown Obsessive-Compulsive Scale - Second Edition (Y-BOCS-II). A blinded independent rater will assess primary outcomes at baseline and the primary endpoint at the end of the second dosing week. Participants will be followed up to 12 months post-second dosing. Participants randomized to waitlist will be rescreened after 7 weeks post-randomization, and begin their delayed treatment phase thereafter if still eligible., Ethics: Written informed consent will be obtained from participants. The institutional review board has approved this trial (protocol v. 1.7; HIC #2000032623)., Discussion: This study seeks to advance our ability to treat refractory OCD, and catalyze future research seeking to optimize the process of psilocybin treatment for OCD through understanding relevant psychological mechanisms. Clinical trial registration : ClinicalTrials.gov, identifier NCT05370911., Competing Interests: TC serves as a continuing faculty member in the Psychedelic-Assisted Therapy Training Program offered by Integrative Psychiatry Institute (IPI), and consults for Transcend Therapeutics. CP serves/has served as a consultant for Biohaven, Teva, Lundbeck, Brainsway, Ceruvia Lifesciences, Transcend Therapeutics, Nobilis Therapeutics, and Freedom Biotech, receives royalties and/or honoraria from Oxford University Press and Elsevier, and has filed a patent on the use of neurofeedback in the treatment of anxiety, which is not relevant to the current work. BK is co-founder and Chief Scientific Advisor for Transcend Therapeutics and has consulted for Ceruvia Lifesciences and Lobe Sciences. CP and BK have filed a patent on the use of psilocybin in the treatment of obsessive-compulsive disorder (#US17/466,111). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ching, Amoroso, Bohner, D’Amico, Eilbott, Entezar, Fitzpatrick, Fram, Grazioplene, Hokanson, Kichuk, Martins, Patel, Schaer, Shnayder, Witherow, Pittenger and Kelmendi.)

Purpose: Patients with atrial fibrillation or flutter (AF) on anticoagulation (AC) for stroke prevention are at an increased risk of bleeding. A common clinical dilemma is deciding when to safely restart AC following a bleed. Although studies have shown better outcomes with re-initiation of AC after hemostasis, there are clinical barriers to restarting AC. Left atrial appendage occlusion (LAAO) is a safe and efficacious alternative for patients who are unable to tolerate AC following major bleeding. We aimed to evaluate the rate of stroke prevention strategies instituted at time of discharge in patients with AF on AC who had been hospitalized for a bleeding event., Methods: We retrospectively identified patients with AF on AC admitted for bleeding between January 2016 and August 2019. The type of AC, form of bleeding, and CHA 2 DS 2 VASc were collected. Stroke prevention strategies upon discharge and at 3 months were noted., Results: One hundred seventy-four patients with AF on AC were hospitalized with a bleeding event, of which 10.9% died. Among patients who survived, AC was restarted in 45.2% of patients, 9.7% were referred for LAAO, and 45.1% were discharged without stroke prevention strategy. At 3 months, 32.6% of patients still had no documented stroke prophylaxis. Those referred for LAAO had, on average, higher CHA 2 DS 2 VASc (5 ± 1 vs 4 ± 1, p = 0.007)., Conclusions: A significant number of patients with AF hospitalized for bleeding were discharged with no plan for stroke prophylaxis. Despite its safety and efficacy, LAAO appears to be an underutilized alternative in AF patients with high bleeding risk., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Hydroxychloroquine has been used for rheumatological diseases for many decades and is considered a safe medication. With the COVID-19 outbreak, there has been an increase in reports associating cardiotoxicity with hydroxychloroquine. It is unclear if the cardiotoxic profile of hydroxychloroquine is previously underreported in the literature or is it a manifestation of COVID-19 and therapeutic interventions. This manuscript evaluates the incidence of cardiotoxicity associated with hydroxychloroquine prior to the onset of COVID-19., Methods: PubMED, EMBASE, and Cochrane databases were searched for keywords derived from MeSH terms prior to April 9, 2020. Inclusion eligibility was based on appropriate reporting of cardiac conditions and study design., Results: A total of 69 articles were identified (58 case reports, 11 case series). The majority (84%) of patients were female, with a median age of 49.2 (range 16-92) years. 15 of 185 patients with cardiotoxic events were in the setting of acute intentional overdose. In acute overdose, the median ingestion was 17,857 ± 14,873 mg. 2 of 15 patients died after acute intoxication. In patients with long-term hydroxychloroquine use (10.5 ± 8.9 years), new onset systolic heart failure occurred in 54 of 155 patients (35%) with median cumulative ingestion of 1,493,800 ± 995,517 mg. The majority of patients improved with the withdrawal of hydroxychloroquine and standard therapy., Conclusion: Millions of hydroxychloroquine doses are prescribed annually. Prior to the COVID-19 pandemic, cardiac complications attributed to hydroxychloroquine were uncommon. Further studies are needed to understand the impact of COVID-19 on the cardiovascular system to understand the presence or absence of potential medication interactions with hydroxychloroquine in this new pathophysiological state., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

A 67-year-old man with a medical history of multiorgan sarcoidosis was admitted to the hospital with skin ulceration and a superimposed polymicrobial infection that had failed outpatient management. The patient's outpatient regimen included doxycycline, ciprofloxacin and moderate-dose prednisone therapy for a coinfection with Pseudomonas aeruginosa and methicillin-susceptible Staphylococcus aureus The patient presented after a syncopal episode initially thought to be due to severe dehydration. Owing to concern for cardiac sarcoidosis as well as worsening skin lesions, he was admitted to the hospital for cardiac monitoring and intravenous antibiotics. On admission, we broadened antibiotic coverage and initiated high-dose steroids at 1 mg/kg/day of prednisone. He was discharged on intravenous antibiotics and a slow steroid taper 3 days later. At the patient's 1-month and 5-month follow-up clinic visits, he demonstrated remarkable improvement of his scalp and facial wounds., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2019. No commercial re-use. See rights and permissions. Published by BMJ.)