RecruitingPhase 2NCT06782724

Psilocybin Therapy for Psychological Distress in Palliative Patients

The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.


Sponsor

University Medical Center Groningen

Enrollment

108 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will the therapeutic effects be rapid and sustained over a 6-month period? Researchers will compare patients receiving two escalating doses of psilocybin (15mg followed by 25mg) against those receiving two low doses (1mg) to see if the higher doses lead to greater improvements in depression, anxiety, demoralization, and quality of life. Participants will: * Attend three preparation sessions with psychotherapists (1-2 hours each) * Undergo two supervised psilocybin dosing sessions (6-8 hours each) * Complete five integration therapy sessions following the dosing sessions * Participate in follow-up assessments at 6 weeks, 3 months, and 6 months * Have access to a digital care platform and peer support groups during the 6-month follow-up period * Optional: Control group participants may receive one high-dose psilocybin session (25mg) after the initial study period


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Psilocybin therapy for people with als (amyotrophic lateral sclerosis), atypical parkinson disease, and other related conditions. The study is currently recruiting participants at 4 locations.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsilocybin therapy

Psilocybin therapy consisting of three preparation, two dosing, and three integration sessions. All sessions will take place in a controlled, safety environment and supported by two study therapists


Locations(4)

National Institute of Mental Health

Prague, Czechia

Bispebjerg Hospital

Copenhagen, Denmark

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Champalimaud Foundation

Lisbon, Portugal

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06782724


Related Trials