Clinical TrialSequentialDepressive DisordersPsilocybinNot yet recruiting

Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression

This Phase II, non-randomised, single-arm sequential dose-finding trial (n=72) will evaluate group retreat psilocybin therapy for healthcare clinicians with symptoms of depression and loss of meaning in their work. It will assess the feasibility, safety, and preliminary clinical effects of different preparation “doses” before a single psilocybin retreat session. Participants will be healthcare clinicians aged 25-70 years who are currently in clinical practice and have moderate or greater depressive symptoms. The study uses three sequential cohorts, each with 8 participants per retreat and 3 retreats per cohort, comparing 7 preparation sessions (6 virtual and 1 in-person), 4 preparation sessions (3 virtual and 1 in-person), and 2 preparation sessions (1 virtual and 1 in-person). The psilocybin dose depends on antidepressant use: 25 mg plus an optional 10 mg booster for those not taking an antidepressant, or 35 mg plus an optional 10 mg booster for those taking an antidepressant. The intervention includes preparation sessions, a single psilocybin session, and integration sessions, with outcomes collected at 1 week, 1 month, and 3 months after the retreat.

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Target Enrollment
72 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

unknown

Study Arms & Interventions

Group Retreat Psilocybin Therapy

experimental

In this non-randomized trial, the dose of psilocybin will be as follows: for participants not taking an antidepressant, the dose will be psilocybin 25 mg + optional booster 10 mg; for participants who are taking an antidepressant the dose will be psilocybin 35 mg + optional booster 10 mg,

Interventions

  • Psilocybin25 - 35 mg
    • single psilocybin session with optional booster 10 mg• 1 doses total

Participants

Ages
25 – 70
Sexes
Male & Female

Inclusion Criteria

  • 1. Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice
  • 2. Age 25-70 years
  • 3. Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded".
  • 4. PHQ-9 score ≥10 (moderate symptoms of depression)
  • 5. Ability to commit to all preparation sessions and retreat attendance
  • 6. English fluency sufficient for group participation
  • 7. Screening laboratory tests within acceptable limits, including liver function tests
  • 8. Negative urine drug screen for non-prescribed psychoactive medications.
  • 9. ECG with QTc \<450 ms
  • 10. Willing to taper and discontinue any supplements with serotonin-like properties, including but not limited to 5-HTP, St. John's Wort, and 'brain food' supplements.
  • 11. For participants of childbearing potential, agree to use to use highly effective contraception. Highly effective contraceptive methods are defined as those that, alone or in combination, result in a low failure rate (less than 1 percent per year), including but not limited to implants, IUDs, contraceptive injections, or contraceptive pills.

Exclusion Criteria

  • 1. Personal or first-degree family history of psychotic disorder or bipolar I disorder
  • 2. Personal major depressive episode prior to entering healthcare as a professional
  • 3. Active suicidal ideation with intent or plan
  • 4. Unstable medical conditions
  • 5. Pregnancy or breastfeeding
  • 6. Hypertension with BP systolic \>150 or diastolic \> 90

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment72 participants
  • Timeline
    Start: 2026-06-01
    End: 2028-07-01
  • Compound
    Psilocybin
  • Topic
    Depressive Disorders

Study Team

Sponsors & Collaborators