CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial
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).
- Status
- recruiting
- Phase
- Phase 2
- Institution
- Section for Affective Disorders; Northern Stockholm Psychiatry
- Principal investigator
- Johan Lundberg, MD PhD
- Start date
- 2024-04-19
- End date
- 2026-12-01
- Registry ID
- NCT06319378
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.