NCT04754061 PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
| NCT ID | NCT04754061 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Depression, Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01-08 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<12 months life expectancy (in the judgment of the palliative care provider) 3. 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 4. Ability to understand and communicate in English or French Exclusion Criteria: 1. Current or previously diagnosed, or first-degree relative, with psychotic or bipolar disorder 2. 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) 3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution 4. Documented moderate or severe dementia diagnosis 5. Inability to provide first-person informed consent 6. Severe or unstable physical symptoms based on the judgment of the palliative care provider 7. Palliative Performance Scale \<30% 8. Cancer with known central nervous system (CNS) involvement or other CNS disease 9. Use of high-dose psychedelic substances in the past year 10. Taking lithium at any dose 11. Taking tramadol at any dose 12. Taking any monoamine oxidase inhibitor at any dose \[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\] 13. Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) (patients can be included if their atypical antipsychotic is either stopped, or if appropriate, substituted with haloperidol 48 hours prior to the start and for the duration of the intervention period and follow-up) 14. Inability to ingest oral capsule 15. Pregnancy or lactation For participants taking either an SSRI or an antipsychotic medication, there are several conditions for participation: (1) the PC provider must approve their participation in the study; (2) the SSRI/anti-psychotic medication dose cannot change for the duration of the intervention trial and follow-up, and; (3) the patient must not be taking more than the maximum allowable trial dose for each SSRI. All trial participants must agree to not take any other psychedelic substance for the duration of the clinical trial and follow-up, and to notify the investigative team of any medication changes during intervention or follow-up. Participants must also agree not to take their benzodiazepine or antipsychotic medication, if applicable, within 12 hours (6 hours pre and 6 hours post) of taking their psilocybin dose (participants will be given detailed instructions about this in their Instruction Leaflet). Participants must also agree not to drive or operate any heavy machinery on any treatment day for the duration of the 4-week intervention.
Contact & Investigator
James Downar, MDCM, MSc
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT04754061 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression, Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04754061 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04754061 currently recruiting?
Yes, NCT04754061 is actively recruiting participants. Contact the research team at jdownar@toh.ca for enrollment information.
Where is the NCT04754061 trial being conducted?
This trial is being conducted at Ottawa, Canada, Ottawa, Canada.
Who is sponsoring the NCT04754061 clinical trial?
NCT04754061 is sponsored by Ottawa Hospital Research Institute. The principal investigator is James Downar, MDCM, MSc at Ottawa Hospital Research Institute. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.