Depression, Anxiety Clinical Trial
Official title:
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical 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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Bruyere Continuing Care | Ottawa | Ontario |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Bruyere Research Institute, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, CHU de Quebec-Universite Laval, Jewish General Hospital, Queen's University, St. Joseph's Healthcare Hamilton, The Ottawa Hospital, William Osler Health System |
Canada,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Rate | Number of patients enrolled divided by number of patients approached | Through study completion, up to 1 year | |
Primary | Intervention Completion Rate | Number of participants who complete the intervention divided by number of participants enrolled | Through study completion, up to 13 months | |
Primary | Follow-up Completion Rate | Number of participants who complete follow-up divided by number of participants enrolled | Through study completion, up to 18 months | |
Primary | Number of Participants With Adverse Events - Change in Blood Pressure | Proportion of participants with systolic blood pressure of >180mmHg or an increase in 40% from baseline measurements | Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks) | |
Primary | Number of Participants With Adverse Events - Change in Heart Rate | Proportion of participants with resting heart rate >100bpm or an increase in 40% from baseline | Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks) | |
Primary | Number of Participants With Adverse Events - Delirium | Proportion of participants who develop delirium, measured by the Confusion Assessment Method or the Family Confusion Assessment Method | Through intervention completion, up to 4 weeks | |
Primary | Number of Participants With Adverse Events - Serotonin Syndrome | Proportion of participants who develop serotonin syndrome, diagnosed by Study Doctor | Through intervention completion, up to 4 weeks | |
Primary | Number of Participants With Adverse Events - Adverse Mood or Behaviour Change | Proportion of participants who report adverse mood or behaviour changes (recorded daily in a participant diary) | Measured at baseline and from enrolment to intervention completion (up to 4 weeks); 2-week and 4-week follow-up | |
Primary | Psychological Distress - Anxiety and Depression | Measured using the Hospital Anxiety and Depression Scale (higher score indicate worse anxiety/depression) | Baseline | |
Primary | Change in Psychological Distress - Anxiety and Depression | Measured using the Hospital Anxiety and Depression Scale (higher score indicate worse anxiety/depression) | Weekly (every Friday) during intervention (4 weeks) | |
Primary | Change in Psychological Distress - Anxiety and Depression | Measured using the Hospital Anxiety and Depression Scale (higher score indicate worse anxiety/depression) | Follow-up (1 day, 2 weeks, 4 weeks, 12 weeks, 24 weeks) | |
Primary | Psychological Distress - Anxiety, Depression, and Well-being | Measured using the Edmonton Symptom Assessment System anxiety, depression, and well-being item scores (score 0-10 for each item - higher scores indicate worse symptoms) | Baseline | |
Primary | Change in Psychological Distress - Anxiety, Depression, and Well-being | Measured using the Edmonton Symptom Assessment System anxiety, depression, and well-being item scores (score 0-10 for each item - higher scores indicate worse symptoms) | Weekly (every Friday) during intervention (4 weeks) | |
Primary | Change in Psychological Distress - Anxiety, Depression, and Well-being | Measured using the Edmonton Symptom Assessment System anxiety, depression, and well-being item scores (score 0-10 for each item - higher scores indicate worse symptoms) | Follow-up (1 day, 2 weeks, 4 weeks, 12 weeks, 24 weeks) | |
Primary | Psychological Distress - Global Impression of Change | Measured using the Patient Global Impression of Change scale (higher scores indicate greater positive change) | Weekly (every Friday) during intervention (4 weeks); 1 day, 2 week, 4 week, 12 week, 24 week follow-up | |
Primary | Dosing | Dose at which therapeutic benefit, if any, is achieved assessed by change in Hospital Anxiety and Depression Scale score (score reduction of 50% indicates therapeutic benefit) | Weekly (each Friday) for intervention period (4 weeks) | |
Primary | Dosing | Dose at which therapeutic benefit, if any, is achieved assessed by Edmonton Symptom Assessment Scale score (two-point score reduction or absolute score less than 3 indicate therapeutic benefit) | Weekly (each Friday) for intervention period (4 weeks) | |
Primary | Dosing | Dose at which therapeutic benefit, if any, is achieved assessed by Global Impression fo Change score (score of 5 or above indicate therapeutic benefit) | Weekly (each Friday) for intervention period (4 weeks) | |
Secondary | Existential Distress | Measured using the Demoralization scale II (SD-II), a 16-item questionnaire that measures loss of meaning and purpose, distress, and coping abilities. | Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up | |
Secondary | Psychological distress | Measured by the Hamilton Depression Rating Scale (HDRS). We will consider a 50% reduction in score from baseline as achieving clinically meaningful improvement. | Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up | |
Secondary | Participant Quality of Life | Measured using the World Health Organization Quality of Life, Brief Version (higher scores indicate higher quality of life) | Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up | |
Secondary | Wish to Die | Measured using the Categories of Attitudes Towards Death Occurrence (scored 1-6 with scores 4-6 indicating a wish to die) | Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up | |
Secondary | Global Distress | Measured using the Distress Thermometer | Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
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