Phase 3
N=30
Frontline Clinician Psilocybin Study
Burnout, Caregiver · Burnout, Professional · COVID-19 · Depression · Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05163496 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale — 21.33; 9.33 score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Psilocybin (Usona Institute) (Drug); Active placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale |
3.67 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale |
3.67 | — |
| SECONDARY Stanford Fulfillment Index |
— | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL5) |
16.67; 6.74 | — |
| SECONDARY Moral Injury Symptom Scale |
— | — |
| SECONDARY Beck Depression Index |
— | — |
Summary
This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic.
Eligibility Criteria
Inclusion Criteria
- Participants must be physicians or nurses with at least 1 month of frontline clinical experience during the COVID pandemic who rate at least 2 of 4 items from the COVID Exposure index as 'more than half the days' during their peak 2 week period of exposure: i. Caring for someone critically ill with COVID-19, or who became critically ill while you were involved; ii. Working longer hours than usual in order to provide assistance or care to individuals with COVID-19; iii. Witnessing or responding to a death related to COVID-19, or losing a patient you had been caring for to COVID-19; iv. Caring for patients who have died without family physically present due to COVID-19 precautions
- Have a Montgomery-Asberg Depression Rating Scale (MADRS) clinician-administered depression score >21, indicating moderately severe symptoms.
- Have had persistent symptoms despite at least one medication and/or therapy trial of standard care treatment for depression.
- English speaking - able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent.
- Must be willing to sign a medical release for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case-by-case basis upon the discretion of the PI.
- Must be driven home after the medication dosing session by a driver (which could be a friend, family, rideshare or taxi).
- Must provide at least one adult to have continuous contact with the participant, provide participant transportation, monitor changes in the participant's behavior, and notify research staff of behavior changes.
- Has been off selective serotonin inhibitors (SSRIs) for at least five half-lives of the drug plus 2 weeks.
- Must avoid taking any psychiatric medications or starting a new psychiatric medication during the study. Should participant's doctor recommend starting a new psychiatric medication, participant will be required to notify the study team and the subject would withdraw from the study
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
- If able to bear children, must have a negative pregnancy test at study entry.
- Are willing to commit to preparation sessions, medication dosing sessions, integration sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts.
Exclusion Criteria
- Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.
- Suicidal ideation with a Columbia Suicide Severity Rating Scale (C-SSRS) > 3
- Current substance abuse disorder (except in the case of mild alcohol use )
- Neuroleptic and SSRI medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician.
- Unstable neurological or medical condition; history of seizure, chronic/severe headaches.
- Positive urine pregnancy test at the time of screening
- Any unstable medical condition that my render study procedures unsafe.
- Any use of psychedelic drugs within the prior 12 months.
- Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin.
Data sourced from ClinicalTrials.gov (NCT05163496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.