NCT06319378

Cancer Related Major Depression Treated With a Single Dose of Psilocybin

CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Section for Affective Disorders; Northern Stockholm Psychiatry · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• MDD

Interventions

Type	Name	Description
DRUG	psilocybin 25 mg sod	psilocybin 25 mg sod
DRUG	psilocybin 1 mg sod	active placebo

Timeline

• Start date: 2024-04-19
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-03-20
• Last updated: 2026-04-13

Locations

4 sites across 1 country: Sweden