Cancer Related Major Depression Treated With a Single Dose of Psilocybin

Summary

The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is: The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9) ≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).

Timeline

Start

2024-04-19

Primary completion

2026-12

Completion

2026-12

Publications

• Morel NS, Stenbaek DS, Lundberg J, Beckman M. Evaluation of a facilitator training program in a randomized controlled trial of psilocybin treatment for depression. BMC Med Educ. 2026 Apr 9;26(1):635. doi: 10.1186/s12909-026-09124-8.

Drugs

Indications