Psilocybin Therapy for Psychological Distress in Palliative Patients

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

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)
• ALS (Amyotrophic Lateral Sclerosis)
• MS (Multiple Sclerosis)
• Major Depressive Disorder (MDD)
• Atypical Parkinson Disease

Interventions

DRUG

Psilocybin 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

Sponsors & Collaborators

• HumanKindLabs

  collaborator UNKNOWN

• University of Copenhagen

  collaborator OTHER

• CTC Clinical Trial Consultants AB

  collaborator INDUSTRY

• OPEN Foundation

  collaborator UNKNOWN

• IESE Business School

  collaborator UNKNOWN

• Uppsala University

  collaborator OTHER

• The Champalimaud Centre, Lisbon, Portugal

  collaborator UNKNOWN

• Stockholm University

  collaborator OTHER

• University of Groningen, The Netherlands

  collaborator UNKNOWN

• National Institute of Mental Health, Czech Republic

  collaborator OTHER

• European Association for Palliative Care (EAPC)

  collaborator UNKNOWN

• Madopa

  collaborator UNKNOWN

• Bispebjerg Hospital

  collaborator OTHER

• European Association of Neurological Associations (EFNA)

  collaborator UNKNOWN

• 29k International AB

  collaborator UNKNOWN

• Lung Alliance Netherlands

  collaborator UNKNOWN

• European Psychiatric Association

  collaborator UNKNOWN

• Norrsken Mind

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2027-01-01

Completion

2028-01-01

Countries

• Czechia
• Denmark
• Netherlands
• Portugal

Study Locations