Psilocybin and Vagus Nerve Stimulation for Depression
(OPTIMIZE Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Sessions
Several hours of preparatory sessions prior to psilocybin dosing
Psilocybin Dosing
Participants receive a single 25 mg dose of psilocybin with psychological support
Post-Dosing Integration
Participants undergo integration sessions to process the psilocybin experience
taVNS/Sham/TAU
Participants receive 7 days of twice daily taVNS, sham taVNS, or treatment as usual
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Psilocybin is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elaine Sandler
Lead Sponsor
Charles Raison
Lead Sponsor
Usona Institute
Collaborator
Emory University
Collaborator
Steadman Philippon Research Institute
Collaborator
Tiny Blue Dot Foundation
Collaborator
Tiny Blue Dot Foundation
Collaborator