Trials
July 3, 2024
Joshua M Poulin, Gregory E Bigford, Krista L Lanctôt et al.
3 citations
A proposed randomized controlled trial will test whether a single 25 mg dose of psilocybin, compared to a placebo, acutely alters cerebral blood flow and functional brain activity in mood-regulating networks in people with major depressive disorder or persistent depressive disorder. Fifty participants from a mood disorders clinic will be randomly assigned to receive either psilocybin or a placebo, with the placebo group later crossing over to receive psilocybin. The study will use arterial spin labelling and blood oxygenation level-dependent functional MRI to measure brain changes intraday and at three weeks. Clinical outcomes will be tracked with the Montgomery-Åsberg Depression Rating Scale and other scales. The work aims to clarify psilocybin's neuroplastic mechanisms and identify early brain-based predictors of treatment response.
Psychiatry Research
December 29, 2025
Omer A. Syed, Sean M. Nestor, M.ishrat Husain et al.
1 citation
Adverse event reports for classic psychedelics and MDMA in the WHO global pharmacovigilance database VigiBase show that most reports were for MDMA (1,573) and LSD (394), with fewer for psilocybin (56), DMT (18), and mescaline (15). The most common adverse events were psychiatric, particularly substance abuse and dependence. Overdose reports made up 1.1 to 1.7% of total adverse events. Pregnancy-related and congenital disorders were rare. Compared to acetaminophen, LSD and MDMA were associated with significantly greater odds of reported alcohol abuse, substance use disorder, and substance dependence, and these odds were also greater than those for oxycodone. This exploratory analysis provides a first look at real-world safety data, though findings are limited by potential underreporting and co-use of other substances.
Research Square
December 28, 2023
Joshua M. Poulin, Gregory E. Bigford, Krista L. Lanctôt et al.
1 citation
About one third of people with depression do not fully respond to standard treatments, and psilocybin may offer a rapid-acting alternative. This registered trial will randomize 36 adults with major depressive or persistent depressive disorder to receive either 25 mg psilocybin or an active placebo (100 mg niacin), then cross over three weeks later so that all participants receive psilocybin. Using serial neuroimaging, the study will test whether psilocybin acutely alters cerebral blood flow and functional brain activity in mood-related networks compared to placebo, and whether those changes persist subacutely. Clinical scales and serum biomarkers will also be collected to explore relationships with treatment response.