Psilocybin and Vagus Nerve Stimulation for Depression

(OPTIMIZE Trial)

Overseen By Program Manager

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Elaine Sandler

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will examine whether the antidepressant effect of a single dose of psilocybin administered with psychological support can be increased and extended via the use of post-dosing transcutaneous auricular Vagus Nerve Stimulation (taVNS), a known inducer of neuroplastic brain processes believed to be involved in the therapeutic effects of psilocybin. In addition, the study will examine objectively measured aspects of real-world social behavior known to promote wellbeing. Finally, the study will explore strategies for improving our ability to identify pre-treatment or early post-treatment behavioral responses to psilocybin predictive of good and bad longer-term therapeutic outcomes.

Research Team

Charles Raison, MD

Principal Investigator

Vail Health Behavioral Health

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Psilocybin (Psychedelic Therapy)
• Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (Neurostimulation)

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.

Participant Groups

Group I: Group 1: Psilocybin + Treatment as Usual + taVNS Experimental Treatment 3 Interventions

Post-psilocybin dosing, Group 1 will receive twice-daily taVNS paired with psychedelic session contextual cues for 7 consecutive days. They will also receive treatment as usual (TAU) comprised of an integration session 1-day, 1-week, and 2-weeks post-psilocybin dosing.

Group II: Group 3: Psilocybin + Treatment as Usual Active Control 2 Interventions

Post-psilocybin dosing, Group 3 will receive treatment as usual (TAU), comprised of an integration session 1 day, 1-week and 2-weeks post-psilocybin dosing.

Group III: Group 2: Psilocybin + Treatment as Usual + Sham taVNS Placebo Group 3 Interventions

Post-psilocybin dosing, Group 2 will receive twice-daily sham taVNS paired with psychedelic session contextual cues for 7 days. They will also receive treatment as usual (TAU) comprised of an integration session 1-day, 1-week, and 2-weeks post-psilocybin dosing.

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+