RecruitingPhase 2NCT06319378

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


Sponsor

Section for Affective Disorders; Northern Stockholm Psychiatry

Enrollment

100 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a single dose of psilocybin — the active compound found in "magic mushrooms" — can treat major depression in people who are living with cancer. It is a carefully supervised clinical trial conducted in Sweden that monitors participants closely before and after the treatment session. **You may be eligible if...** - You are between 20 and 80 years old - You read, speak, and understand Swedish - You have been diagnosed with a malignant cancer (any type from C00 to C97) - You have a diagnosis of major depressive disorder related to your cancer - You are at least 1 month past your cancer diagnosis - Women of childbearing potential must use effective contraception during the study **You may NOT be eligible if...** - You have a personal or family history of psychosis, schizophrenia, or bipolar disorder - You have a cardiovascular condition that makes psilocybin unsafe - You are taking certain medications (such as SSRIs or lithium) that interact with psilocybin - You are pregnant, breastfeeding, or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpsilocybin 25 mg sod

psilocybin 25 mg sod

DRUGpsilocybin 1 mg sod

active placebo


Locations(4)

region Västra Götaland

Gothenburg, Göteborg, Sweden

Norra Stockholms Psykiatri

Stockholm, Stockholm County, Sweden

Psykiatriska Kliniken, Akademiska Sjukhuset

Uppsala, Uppsala County, Sweden

Örebro sjukhus

Örebro, Örebro County, Sweden

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NCT06319378


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