RecruitingPhase 2NCT06512194

Investigation to Understand and Optimize Psilocybin

An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)


Sponsor

Charles Raison

Enrollment

141 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating psilocybin — the active compound in psychedelic mushrooms — as a potential treatment for major depressive disorder (MDD). The trial aims to better understand how psilocybin works and how to optimize its use in a clinical setting. **You may be eligible if...** - You have a current diagnosis of major depressive disorder (MDD) - Your depressive episode has been ongoing for at least 60 consecutive days - You have been medically evaluated and cleared to participate safely **You may NOT be eligible if...** - You have a personal or immediate family history of psychosis, schizophrenia, or bipolar disorder - You have active suicidal thoughts with a specific plan within the past 2 weeks - You have a history of seizures or significant cardiovascular disease - You have certain other psychiatric or medical conditions that could affect your safety or the study results - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsilocybin

The psilocybin used in this study is synthesized under Good Manufacturing Practice (GMP) guidelines and is provided in a capsule containing 25 mg of synthetic psilocybin.

DEVICETranscutaneous Auricular Vagus Nerve Stimulation (taVNS)

Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear.

DEVICESham taVNS

Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear. In the sham condition, the device will simulate the sensations of active taVNS without delivering therapeutic stimulation.


Locations(1)

Vail Health Behavioral Health

Edwards, Colorado, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06512194


Related Trials