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Psilocybin Therapy for Psychological Distress in Palliative Patients

Study acronym: PsyPal
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2025 to Jul 1, 2025 · Study sites: 0 to 4v2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to Jul 1, 2025
    • Study sites: 0 to 4
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University Medical Center Groningen
173 trials monitored
See 3 trials at risk
Depression
2,998 trials monitored
See 166 trials at risk
Parkinson's Disease
1,435 trials monitored
See 62 trials at risk
COPD
1,068 trials monitored
See 31 trials at risk
and 2 more diseases
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
Trial Details
NCT Number NCT06782724
Lead Sponsor University Medical Center Groningen
Collaborators: HumanKindLabs, University of Copenhagen, CTC Clinical Trial Consultants AB, OPEN Foundation, IESE Business School, Uppsala University, The Champalimaud Centre, Lisbon, Portugal, Stockholm University, University of Groningen, The Netherlands, National Institute of Mental Health, Czech Republic, European Association for Palliative Care, Madopa, Bispebjerg Hospital, European Association of Neurological Associations (EFNA), 29k International AB, Lung Alliance Netherlands, European Psychiatric Association, Norrsken Mind
Conditions COPD (Chronic Obstructive Pulmonary Disease), ALS (Amyotrophic Lateral Sclerosis), MS (Multiple Sclerosis), Major Depressive Disorder (MDD), Atypical Parkinson Disease
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov