PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered via oral capsules by the participant. Feasibility (recruitment rate, rate of intervention and follow-up completion), safety (rate of adverse events), dosing, and preliminary efficacy (depression, anxiety, overall well-being, and global impression of change) will be measured.
Eligibility criteria
Qualifiers
Patients >/=18 years of age
Advanced illness under palliative care management, defined as having 1 to <12 months life expectancy (in the judgment of the palliative care provider)
Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety or Well-being item of the Edmonton Symptom Assessment System
Ability to understand and communicate in English or French
Disqualifiers
Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder
Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those considering or being assessed for MAiD will still be eligible)
Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution
Documented moderate or severe dementia diagnosis
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Ottawa Hospital Research Institute
Lead sponsor
University of Ottawa
Sponsor institution
Bruyère Health Research Institute.
Collaborator
The Ottawa Hospital
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
CHU de Quebec-Universite Laval
Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator
Jewish General Hospital
Collaborator
William Osler Health System
Collaborator
Queen's University
Collaborator
Source ClinicalTrials.gov