Study of a Single Oral Dose of Psilocybin 25 mg to Treat Major Depression in Adults with Cancer Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial

What this Trial Is About

Researchers are evaluating the antidepressant effects of a single oral dose of psilocybin in patients aged 20 to 80 who have major depressive disorder related to cancer. This randomized, placebo-controlled trial compares the effects of a 25 mg dose of psilocybin to an active placebo dose of 1 mg. The study focuses on patients with moderate to severe depression occurring after cancer diagnosis, with at least 12 months of expected survival and a willingness to avoid other antidepressant treatments during the study. Participants will receive either a single oral dose of 25 mg psilocybin or 1 mg as an active placebo. The trial includes multiple assessment points, including days 8, 42, 90, and 180 after dosing, to evaluate changes in depressive symptoms and related measures. The study uses a double-blind design to compare the two doses while monitoring safety and adherence. Participants must have a support person to accompany them home after dosing. Throughout the study, participants will attend preparatory and follow-up visits, complete standardized depression questionnaires such as the MADRS, PHQ-9, and others, and undergo clinical evaluations. The primary outcome is the level of depression measured on day 42. Secondary measures assess anxiety, quality of life, and functional status up to day 180. Safety monitoring and adherence checks are included, with the total study participation lasting approximately six months.

Cancer Related Major Depression Treated With a Single Dose of Psilocybin