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Phase 3 N=30 Randomized Triple-blind Treatment

Frontline Clinician Psilocybin Study

Burnout, Caregiver · Burnout, Professional · COVID-19 · Depression · Post Traumatic Stress Disorder

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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