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Active Not Recruiting
NCT04754061
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Conditions: Depression, Anxiety, Distress, Emotional
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 20
Sponsor: Ottawa Hospital Research Institute
Location: The Ottawa Hospital Ottawa Ontario
Summary
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
Inclusion Criteria:
1. Patients \>/=18 years of age
2. Advanced illness under palliative care management, defined as having 1 to \
Source: ClinicalTrials.gov (NCT04754061). StuddyBuddy aggregates publicly available trial information.
