Psilocybin and Vagus Nerve Stimulation for Depression
This study is looking at how a single dose of psilocybin, a synthetic compound, might help people with depression. All participants will receive 25 mg of psilocybin with psychological support. After the psilocybin dose, some participants will also receive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), a device that gently stimulates the ear, or a sham (inactive) taVNS device. Researchers want to see if these interventions improve depression symptoms, social activity, and quality of life. You may be able to join if you are 18-70 years old, have been diagnosed with Major Depressive Disorder (MDD) for at least 60 days, and are otherwise healthy. The study is currently recruiting 141 participants.
- Study design
- This interventional study plans to enroll 141 adults. All participants will receive psilocybin, and then be randomly assigned to receive active taVNS, sham taVNS, or no taVNS.
- What's involved
- You will have preparatory sessions before receiving psilocybin, a dosing session with facilitators, and several post-dosing integration sessions. If assigned to taVNS or sham taVNS, you will use the device twice daily for 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depression symptoms and quality of life will be measured at Baseline 2 and again 8 weeks after the psilocybin dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigation to Understand and Optimize Psilocybin
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charles Raison, MD · PRINCIPAL_INVESTIGATOR · Vail Health Behavioral Health
Who to contact
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What this trial measures
- Montgomery-Åsberg Depression Rating Scale (MADRS) scoreBaseline 2, Week 8 Post-Psilocybin Dosing
The MADRS is a 10-item depression rating scale that includes questions on the following symptoms: 1. Reported sadness, 2. Apparent sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts. Items are scored via a blinded clinical interview and rated to capture the patient's clinical state over the prior week. Each item yields a score of 0 to 6, and higher scores indicate more severe depression. The overall score ranges from 0 to 60. For this study, the structured MADRS interview will be used.
- PROMIS Ability to Participate in Social Roles and Activities - Short Form 8aBaseline 2, Week 8 Post-Dose
An 8-item validated measure assessing an individual's perceived ability to engage in social roles and activities, such as work, family responsibilities, and leisure. Participants rate each item on a 5-point Likert scale. Total score can range from 8 to 40 with higher scores indicating greater functional ability and social participation.
- Quality of Life Enjoyment and Satisfaction Questionnaire Short-Form (Q-LES-Q) scoreBaseline 2, Week 8 Post-Dose
The Short Form version (Q-LES-Q-SF) will be used in this trial. The measure contains 16 items that assess quality of life. A total score is derived from summing the first 14 items on the scale, with the last 2 items serving as stand-alone queries. Total score can range from 14 to 70 with higher scores indicating better quality of life.