What is the mechanism of action of this treatment?

Common treatments for burnout, such as psilocybin and selective serotonin reuptake inhibitors (SSRIs), primarily act on serotonin pathways in the brain. Psilocybin targets the 5-HT2A receptor, which can help alleviate depressive symptoms and improve emotional resilience by enhancing cognitive flexibility and mood regulation. SSRIs increase serotonin levels by inhibiting its reuptake, thereby improving mood and reducing anxiety. These mechanisms are crucial for burnout patients as they address the core symptoms of emotional exhaustion and depression, potentially leading to improved mental health and well-being.

What side effects are associated with this type of intervention?

Common side effects of psilocybin and similar psychoactive treatments for burnout include transient anxiety, nausea, dizziness, and perceptual changes. These effects are usually short-lived and occur during the acute phase of treatment. Psychological effects such as emotional distress or confusion may also occur but are typically managed with psychological support.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for burnout. However, treatments for conditions with overlapping symptoms, such as depression, include selective serotonin reuptake inhibitors (SSRIs) and other antidepressants. Psilocybin, which is being studied for its potential to alleviate depressive symptoms and burnout, is not yet FDA-approved for these indications. Current research is exploring its efficacy and safety in this context.

What other types of research exist?

Promising novel alternatives to psilocybin for treating burnout in 2024 include MDMA-assisted psychotherapy, which has shown efficacy in reducing anxiety and psychological distress, and ketamine, which has rapid antidepressant effects. Both treatments have been studied for their impact on mental health conditions and may offer benefits for burnout patients.

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Psychedelic

Psilocybin Therapy for Clinician Burnout and Depression

Phase 3

Waitlist Available

Led By Anthony Back, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin

Unstable neurological or medical condition; history of seizure, chronic/severe headaches

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy

Awards & highlights

Pivotal Trial

Summary

This trial investigates whether a single dose of psilocybin, combined with therapy sessions, can help reduce depression and burnout in healthcare workers affected by their frontline roles during the COVID pandemic. Psilocybin may change brain activity to improve mood, especially when paired with supportive therapy. The study will compare the effects of psilocybin over time. Psilocybin has shown promise in reducing depression and anxiety in patients with life-threatening cancer, according to previous studies.

Who is the study for?

This trial is for English-speaking physicians and nurses who have faced significant stress from frontline work during the COVID pandemic, with moderate to severe depression symptoms. They must not be on SSRIs or start new psychiatric meds during the study, need a negative pregnancy test if applicable, and commit to all sessions and evaluations. A support person must be available for transportation and monitoring post-dosing.

What is being tested?

The study tests the impact of a single dose of psilocybin combined with psychotherapy on healthcare workers' depression and burnout due to COVID-19 related stress. Participants will also receive pre- and post-dose therapy sessions to help integrate their experiences.

What are the potential side effects?

Potential side effects include temporary changes in perception, mood swings, dizziness, nausea, intensified emotions or memories during treatment. Long-term side effects are unknown but could involve persistent alterations in mood or thought patterns.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking tramadol due to its risks with psilocybin.

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I do not have a history of seizures or chronic severe headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mental Depression

Moral injury symptom scale

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Psilocybin armExperimental Treatment1 Intervention

psychedelic assisted psychotherapy + 25mg psilocybin

Group II: PlaceboActive Control1 Intervention

Psychedelic assisted psychotherapy + 250mg niacin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin (Usona Institute)

2022

Completed Phase 3

~30

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burnout, such as psilocybin and selective serotonin reuptake inhibitors (SSRIs), primarily act on serotonin pathways in the brain. Psilocybin targets the 5-HT2A receptor, which can help alleviate depressive symptoms and improve emotional resilience by enhancing cognitive flexibility and mood regulation. SSRIs increase serotonin levels by inhibiting its reuptake, thereby improving mood and reducing anxiety. These mechanisms are crucial for burnout patients as they address the core symptoms of emotional exhaustion and depression, potentially leading to improved mental health and well-being.