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New treatment option for Psychological Distress
Official title Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)
ClinicalTrials.gov ID: NCT07063862
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-daily, being studied as a potential treatment for psychological distress.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients \>/=18 years of age with advanced illness under palliative care management, defined as having an estimated 2 to 12 months life expectancy...
- Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety, or Well-being item of the Edmonton Symptom...
- Living situation falls under one of two categories:
- Living in the community (i.e., receiving palliative care as an outpatient or through community home visits)
- Living in a chronic care inpatient facility (i.e., receiving long-term supportive care because care is unable to be provided in a community home -...
You likely can't join if
- 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 how well it works (this criteria is meant to...
- 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
- Inability to provide first-person informed consent
- Inability to complete assessments via telephone or video-conferencing platform
See the full eligibility criteria
- Patients \>/=18 years of age with advanced illness under palliative care management, defined as having an estimated 2 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-revised (ESAS-r)
- Living situation falls under one of two categories:
- Living in the community (i.e., receiving palliative care as an outpatient or through community home visits)
- Living in a chronic care inpatient facility (i.e., receiving long-term supportive care because care is unable to be provided in a community home - e.g., ALS) and have a family member who can administer the...
- Ability to understand and communicate in English or French
- For patients in community settings, patients must be able to have another individual present with them during and for 2 hours after they take their psilocybin/placebo dose for the first week of the intervention period
- 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 how well it works (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those...
- 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
- Inability to provide first-person informed consent
- Inability to complete assessments via telephone or video-conferencing platform
- Severe or unstable physical symptoms based on the judgment of the palliative care provider
- Palliative Performance Scale (PPS) \<50%\
- Cancer with known central nervous system (CNS) involvement or other CNS disease
- Use of high-dose psychedelic substances in the past year
- Taking lithium at any dose
- Taking tramadol at any dose
- Taking tapentadol at any dose
- 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...
- Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) a. Note: patients can be included if their atypical...
- No enteral route of drug administration available
- Pregnancy or lactation
- Does not apply to the open-label access or open-label extension phases (since participants are expected to decline in overall health and function from baseline due to natural disease progression towards the end of...
The study team makes the final eligibility decision.
Where it's taking place
- Brampton, Ontario, Canada
- Kingston, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brampton, Ontario, Canada; Kingston, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.