Actively Recruiting
Psilocybin Therapy for Psychological Distress in Palliative Patients
Led by University Medical Center Groningen · Updated on 2026-05-08
108
Participants Needed
4
Research Sites
130 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
H
HumanKindLabs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Psilocybin Therapy for Psychological Distress in Palliative Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with COPD, ALS, MS, or atypical Parkinsonian disorder
- Meet ICD-10 criteria for major depressive disorder
- Have a MADRS score greater than 19
- Have a life expectancy of at least 6 months
- At least 18 years old
- Have an identified caregiver or support person
- Able to read and understand consent and study materials in a local language
- Able and willing to follow study requirements including attending sessions and evaluations
- Able to swallow capsules
You will not qualify if you...
- Used psychedelic substances in the past 6 months
- Currently receiving treatment for other psychiatric disorders more significant than depression
- Diagnosed with schizophrenia spectrum, psychotic disorders, or bipolar I/II disorder
- Have a first-degree relative with schizophrenia spectrum, bipolar I disorder, or other psychotic disorders
- Significant suicide risk or recent suicide attempts
- Active alcohol or drug use disorder
- Ongoing treatment with antipsychotic drugs
- Unwilling or unable to pause formal psychotherapy during the study
- Neurological conditions like epilepsy, brain injuries, or intracranial tumors
- Disease-specific exclusions such as unresolved pulmonary infection, significant cognitive deficits, dementia, or severe disability scores
- Recent stroke, myocardial infarction, uncontrolled hypertension, significant arrhythmia, or QTc prolongation
- Moderate to severe liver impairment
- Insulin-dependent diabetes or risk of hypoglycemia requiring medical intervention
- Any medical or psychological condition that makes the patient unsuitable for the study
- Allergy or intolerance to study drug materials
- Cognitive assessment score below defined threshold
- Recent or planned changes in antidepressant medication during intervention
- Pregnancy, nursing, or unwillingness to use effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
National Institute of Mental Health
Prague, Czechia
Actively Recruiting
2
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
3
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Actively Recruiting
4
Champalimaud Foundation
Lisbon, Portugal
Actively Recruiting
Research Team
R
Robert A Schoevers, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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