This randomised placebo-controlled trial (n=100) aims to compare the antidepressant effect of a single oral dose of psilocybin 25 mg with 1 mg in patients with cancer-related major depressive disorder (MDD).
Led by the Section for Affective Disorders at Northern Stockholm Psychiatry, the study focuses on individuals aged 20 to 80 years, experiencing a current depressive episode at least one month after cancer diagnosis, with a life expectancy of at least 12 months. Participants must be willing to abstain from other psychotherapeutic or antidepressant treatments during the study period and have a moderate to severe depressive episode with a Patient Health Questionnaire (PHQ-9) score of at least 10. They must also meet specific physical health criteria and be able to read, speak, and understand Swedish.
The trial aims to assess changes in depressive symptoms, with primary outcomes measured using the Montgomery Asberg Depression Rating Scale (MADRS) at day 42, and secondary outcomes including MADRS-S, Sheehan Disability Scale (SDS), Clinical Global Impression (CGI), Euroquol 5 Dimension scale (EQ5D-5L), and others at various time points up to day 180.
The trial employs a randomised controlled design with a 2:1 ratio, involving two arms: one receiving psilocybin 25 mg (active), and the other receiving psilocybin 1 mg (active placebo).
Recruitment is ongoing across multiple sites in Sweden, including Göteborg, Stockholm, Uppsala, and Örebro. The study is estimated to start in April 2024 and complete by December 2025.
Trial Details
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