Spots Global Cancer Trial Database for Cancer Related Major Depression Treated With a Single Dose of Psilocybin

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Trial Identification

Brief Title: Cancer Related Major Depression Treated With a Single Dose of Psilocybin

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

Study ID: NCT06319378

Conditions

MDD

Interventions

psilocybin 25 mg sod

psilocybin 1 mg sod

Study Description

Brief 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).

Detailed Description: