Understanding and Optimizing Psilocybin for Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigation examines the effects of a single dose of psilocybin on symptoms of depression, combined with psychological support. It will assess the impact of post-dosing interventions, including transcutaneous auricular vagus nerve stimulation (taVNS), on psychological and behavioral outcomes. The study aims to evaluate real-world social behavior and identify early behavioral responses that may correlate with long-term treatment outcomes. A total of 141 adults with major depressive episodes will participate, receiving preparatory sessions and ongoing support throughout the process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Current diagnosis of Major Depressive Disorder (MDD), with a depressive episode lasting ≥ 60 consecutive days at the time of screening, as confirmed by structured clinical interview

Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject.

Exclusion Criteria:

History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results (e.g., bipolar disorder, psychosis, seizure disorder, or cardiovascular disease).

Known family history of a psychotic disorder (e.g., schizophrenia or schizoaffective disorder) in a first-degree relative (biological parent, full sibling, or child).

Current active suicidal ideation with a specific plan within the prior 2 weeks, as assessed via clinical interview and validated instrument (e.g., C-SSRS).

Suicide attempt within the prior 6 months, regardless of intent or lethality.

Current diagnosis of a substance use disorder

Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).

Unwilling or unable to discontinue prescription psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, lithium, anticonvulsants, or mood stabilizers) for the duration of study participation, including any necessary washout period as determined by the investigator.

Any condition, finding, or behavior (including suspected deception or noncompliance) that, in the opinion of the investigator, renders the participant unsuitable for the study or likely to interfere with the integrity of the data or safety of the subject.

Where it's running

• Vail Health Behavioral Health
  Edwards, Colorado, United States Recruiting

Study contacts

• Principal investigator: Charles Raison, MD — Vail Health Behavioral Health
• Study coordinator: Program Manager
• Email: bhic@vailhealth.org
• Phone: (970) 855-7374

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.