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
Patient meets ICD-10 criteria for major depressive disorder documented through the com-pletion of the mood section of the Mini International Neuropsychiatric Interview by a screen-ing psychologist or physician.
Patient has a MADRS score of > 19.
Patient should have a life expectancy of at least 6 months (assessed by study physician).
Patient is at least 18 years of age.
Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline).
Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than depression / distress.
Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features (except substance/medication-induced or due to another medical condition) or bipolar I/II disorder.
Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders.
University Medical Center Groningen
Lead sponsor
HumanKindLabs
Collaborator
University of Copenhagen
Collaborator
CTC Clinical Trial Consultants AB
Collaborator
OPEN Foundation
Collaborator
IESE Business School
Collaborator
Uppsala University
Collaborator
The Champalimaud Centre, Lisbon, Portugal
Collaborator
Stockholm University
Collaborator
University of Groningen, The Netherlands
Collaborator
National Institute of Mental Health, Czech Republic
Collaborator
European Association for Palliative Care (EAPC)
Collaborator
Madopa
Collaborator
Bispebjerg Hospital
Collaborator
European Association of Neurological Associations (EFNA)
Collaborator
29k International AB
Collaborator
Lung Alliance Netherlands
Collaborator
European Psychiatric Association
Collaborator
Norrsken Mind
Collaborator