Actively Recruiting
The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD
Led by University Medical Center Groningen · Updated on 2026-05-08
108
Participants Needed
4
Research Sites
52 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
This research aims to evaluate psilocybin therapy for treating depression and psychological distress in adult patients with chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), or atypical and advanced Parkinsonian disorder (APD), all with at least a six-month life expectancy. The study focuses on whether psilocybin therapy can safely reduce depressive symptoms compared to a low-dose control and if these effects are rapid and sustained over six months. It also explores impacts on anxiety, demoralization, quality of life, and caregiver burden. Participants will receive psilocybin therapy through three phases: preparation, dosing, and integration. The preparation phase involves three psychotherapy sessions to build therapeutic alliance and prepare for dosing. The dosing phase includes two supervised sessions with escalating doses of psilocybin (15 mg followed by 25 mg) or two low doses (1 mg) for the control group. Integration consists of five psychotherapy sessions to address experiences and psychological themes. Control group participants may optionally receive a high-dose psilocybin session after the initial study period. All dosing and therapy sessions occur in a controlled, supervised setting with trained therapists. During the study, participants will attend preparation, dosing, and integration sessions over about ten weeks, with follow-up assessments at 6 weeks, 3 months, and 6 months after dosing. Researchers will monitor depressive symptoms, anxiety, demoralization, quality of life, adverse events, and other psychological and biological markers. Participants will have access to a digital care platform and peer support during follow-up. Safety and long-term effects of psilocybin therapy will be evaluated throughout the study period.
CONDITIONS
Brief 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/advanced Parkinsonian disorder as defined by specific medical criteria
- Meets ICD-10 criteria for major depressive disorder with a MADRS score greater than 19
- Life expectancy of at least 6 months
- At least 18 years old
- Has an identified caregiver or support person
- Able to read, understand informed consent, and complete study scales
- Willing and able to adhere to all study visits and requirements
- Able to ingest capsules
You will not qualify if you...
- Use of psychedelic substances within the past 6 months
- Active treatment for other psychiatric disorders more severe than depression
- Diagnosis of schizophrenia spectrum, psychotic disorders, or bipolar I/II disorder
- First-degree relative with schizophrenia spectrum or bipolar I disorder
- Significant suicide risk or recent suicide attempts
- Current alcohol or drug use disorder
- Ongoing antipsychotic drug treatment
- Unwilling or unable to pause psychotherapy during days 0-42
- Neurological conditions conflicting with study protocol
- Disease-specific exclusions such as recent COPD exacerbation, cognitive deficits for ALS/MS/APD, or dementia
- Recent stroke or myocardial infarction, uncontrolled hypertension, significant arrhythmia, or QTc prolongation
- Moderate to severe liver impairment
- Insulin-dependent diabetes or risk of hypoglycemia
- Allergy or intolerance to study drug materials
- Cognitive assessment below threshold on Montreal Cognitive Assessment
- Recent change or planned change in antidepressant medication
- Pregnant, nursing, or unwilling to use effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 weeks
Participants attend three psychotherapy sessions to build a therapeutic alliance, create a treatment plan, and learn about psilocybin's effects and coping strategies during dosing.
3 visits (in-person psychotherapy sessions)
Duration - Approximately 3 weeks
Participants receive two supervised psilocybin dosing sessions: a moderate dose followed two weeks later by a high dose (or low doses for control), each lasting 6-8 hours in a controlled setting with therapist support.
2 visits (in-person dosing sessions)
Duration - Approximately 4 weeks
Participants engage in five psychotherapy sessions after dosing to process their experiences, address psychological and existential topics related to their illness and life, and receive clinical assessments.
5 visits (in-person psychotherapy sessions)
Duration - 6 months
Participants are followed for 6 months after completing therapy, with access to a digital care platform and peer support groups, to monitor safety, psychological outcomes, and healthcare resource use.
Ongoing remote monitoring and support
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
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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