PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
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
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin
DrugPhase 1 (week 1): all enrolled participants will take a single 1mg oral dose of psilocybin once per day on Monday and Thursday. If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 2 for week 2. Phase 2: The participant will take a single 1mg oral dose of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 3 for week 3. Phase 3: The participant will take two 1mg oral doses (2mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 4 for week 4. Phase 4 (maximum allowable dose): The participant will take three 1mg oral doses (3mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Psilocybin MicrodosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Number of patients enrolled divided by number of patients approached
Time frame
Through study completion, up to 1 year2
Intervention Completion Rate
Number of participants who complete the intervention divided by number of participants enrolled
Time frame
Through study completion, up to 13 months3
Follow-up Completion Rate
Number of participants who complete follow-up divided by number of participants enrolled
Time frame
Through study completion, up to 18 months4
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
Time frame
Measured at baseline and daily (Mon-Fri) from enrolment to intervention completion (up to 4 weeks)Secondary outcomes
1
Existential Distress
Measured using the Demoralization scale II (DS-II), a 16-item questionnaire that measures loss of meaning and purpose, distress, and coping abilities. Each item is rated as a 0 (Never), 1 (Sometimes), or 2 (Often). The 16 items are then summed to create a total score. The highest total score that can be obtained is 32. Higher total scores indicate higher levels of demoralization.
Time frame
Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up2
Psychological distress
Measured by the Hamilton Depression Rating Scale (HDRS), a 17-item questionnaire. We will consider a 50% reduction in score from baseline as achieving clinically meaningful improvement. Each item varies in the maximum value it can be rated at (an item can be rated from 0-2, 0-3, or 0-4). The highest total score that can be obtained is 53. All scores from the 17-items are summed for a total score. Higher total scores indicate increased severity of depression.
Time frame
Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up3
Participant Quality of Life
Measured using the World Health Organization Quality of Life, Brief Version (higher scores indicate higher quality of life)
Time frame
Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-up4
Wish to Die
Measured using the Categories of Attitudes Towards Death Occurrence (scored 1-6 with scores 4-6 indicating a wish to die)
Time frame
Baseline (Friday prior to first dose administered on a Monday); 1 day, 2 week, 4 week, 12 week, 24 week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
University of Ottawa
Sponsor institution
Bruyère Health Research Institute.
Collaborator
The Ottawa Hospital
Collaborator
St. Joseph's Healthcare Hamilton
Collaborator
CHU de Quebec-Universite Laval
Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator
Jewish General Hospital
Collaborator
William Osler Health System
Collaborator
Queen's University
Collaborator
Source ClinicalTrials.gov