141 Participants Needed

Psilocybin and Vagus Nerve Stimulation for Depression

(OPTIMIZE Trial)

PM
Overseen ByProgram Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current prescription psychotropic medications (like antidepressants, antipsychotics, or mood stabilizers) for the duration of the trial.

Is psilocybin safe for use in humans?

Psilocybin, found in magic mushrooms, has been used historically for its mind-altering effects. Studies suggest that under controlled conditions, psilocybin does not worsen certain heart conditions and may protect against cell injury, but caution is advised with higher doses. It can cause rapid effects on the central nervous system, including hallucinations and physical symptoms like ataxia (loss of control of body movements) and hyperkinesis (increased movement).12345

How is the drug psilocybin unique in treating depression?

Psilocybin is unique in treating depression because it is a psychedelic drug that can induce rapid improvements in depressive symptoms with just a single dose, especially when combined with psychological support. Unlike traditional antidepressants, psilocybin works quickly and its effects can last for several weeks.12367

What data supports the effectiveness of this drug for depression?

Research shows that psilocybin, found in magic mushrooms, has been effective in reducing symptoms of depression, even in patients who haven't responded to other treatments. Clinical trials have demonstrated that psilocybin can lead to significant and rapid improvements in depression symptoms.89101112

Who Is on the Research Team?

CR

Charles Raison, MD

Principal Investigator

Vail Health Behavioral Health

Are You a Good Fit for This Trial?

This trial is for individuals with depression. Participants must meet certain health criteria to be included, but specific inclusion and exclusion details are not provided in the information given.

Inclusion Criteria

I can speak English or Spanish and can fill out forms in one of these languages.
I am generally in good health.
I have been diagnosed with major depression for at least 60 days.
See 1 more

Exclusion Criteria

Endorses current active suicidal ideation with a specific plan in the prior 2 weeks
Abnormal electrocardiogram (ECG) at screening
I do not have a substance use disorder that would cause withdrawal symptoms during a 7-10 hour period.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Several hours of preparatory sessions prior to psilocybin dosing

1 week

Psilocybin Dosing

Participants receive a single 25 mg dose of psilocybin with psychological support

1 day
1 visit (in-person)

Post-Dosing Integration

Participants undergo integration sessions to process the psilocybin experience

2 weeks
3 visits (in-person)

taVNS/Sham/TAU

Participants receive 7 days of twice daily taVNS, sham taVNS, or treatment as usual

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Multiple assessments up to 8 weeks post-dose

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin
  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Trial Overview The study tests if psilocybin's antidepressant effects can be enhanced and prolonged by post-dose transcutaneous auricular Vagus Nerve Stimulation (taVNS). It compares usual treatment, taVNS, sham taVNS (placebo), and psilocybin with psychological support.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 1: Psilocybin + taVNSExperimental Treatment2 Interventions
Group II: Group 3: Psilocybin + No taVNSActive Control1 Intervention
Group III: Group 2: Psilocybin + Sham taVNSPlacebo Group2 Interventions

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Psilocybin for:
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Approved in European Union as Psilocybin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elaine Sandler

Lead Sponsor

Trials
1
Recruited
140+

Charles Raison

Lead Sponsor

Trials
1
Recruited
140+

Usona Institute

Collaborator

Trials
18
Recruited
1,100+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Steadman Philippon Research Institute

Collaborator

Trials
11
Recruited
700+

Tiny Blue Dot Foundation

Collaborator

Trials
9
Recruited
640+

Tiny Blue Dot Foundation

Collaborator

Trials
10
Recruited
660+

Published Research Related to This Trial

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
A single dose of psilocybin (0.5-20 mg/kg) significantly increases the expression of genes related to neuroplasticity in the prefrontal cortex and hippocampus, suggesting its potential therapeutic effects for mental health disorders.
The study highlights that psilocybin's effects on gene expression are dose-dependent and predominantly observed in the prefrontal cortex, emphasizing the need to assess both gene expression and protein translation to understand its rapid effects.
Transcriptional regulation in the rat prefrontal cortex and hippocampus after a single administration of psilocybin.Jefsen, OH., Elfving, B., Wegener, G., et al.[2022]
Psilocybin has shown promise in clinical trials for reducing symptoms of depression, indicating its potential as a novel treatment option.
Patients with treatment-resistant depression (TRD) may benefit the most from psilocybin therapy, although the risks associated with its use are still not fully understood.
Assessing potential of psilocybin for depressive disorders.Kozak, Z., Johnson, MW., Aaronson, ST.[2023]

Citations

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Transcriptional regulation in the rat prefrontal cortex and hippocampus after a single administration of psilocybin. [2022]
Assessing potential of psilocybin for depressive disorders. [2023]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
[Hallucinogenic mushrooms]. [2018]
DARK Classics in Chemical Neuroscience: Psilocybin. [2019]
The pharmacology of psilocybin. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Intravenous mushroom poisoning. [2019]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
The development of psilocybin therapy for treatment-resistant depression: an update. [2023]
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