Active — Not RecruitingPhase 1/2

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)

Canada20 participantsStarted 2024-01-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Rate

Timeframe: Through study completion, up to 1 year

Intervention Completion Rate

Timeframe: Through study completion, up to 13 months

Follow-up Completion Rate

Timeframe: Through study completion, up to 18 months

Number of Participants With Adverse Events - Change in Blood Pressure

Timeframe: Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks)

Number of Participants With Adverse Events - Change in Heart Rate

Timeframe: Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks)

Number of Participants With Adverse Events - Delirium

Timeframe: Through intervention completion, up to 4 weeks

Number of Participants With Adverse Events - Serotonin Syndrome

Timeframe: Through intervention completion, up to 4 weeks

Trial details

NCT IDNCT04754061

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

View on ClinicalTrials.gov More Depression, Anxiety trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

What they're measuring

Recruitment Rate

Timeframe: Through study completion, up to 1 year

Intervention Completion Rate

Timeframe: Through study completion, up to 13 months

Follow-up Completion Rate

Timeframe: Through study completion, up to 18 months

Number of Participants With Adverse Events - Change in Blood Pressure

Timeframe: Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks)

Number of Participants With Adverse Events - Change in Heart Rate

Timeframe: Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks)

Number of Participants With Adverse Events - Delirium

Timeframe: Through intervention completion, up to 4 weeks

Number of Participants With Adverse Events - Serotonin Syndrome

Timeframe: Through intervention completion, up to 4 weeks