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Psychedelic Therapy

Psilocybin and Vagus Nerve Stimulation for Depression (OPTIMIZE Trial)

Phase 2
Waitlist Available
Led By Elaine Sandler, MD
Research Sponsored by Elaine Sandler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration
Be older than 18 years old
Must not have
Known family history of a psychotic disorder in a first degree relative
Current presence of a substance use disorder (including tobacco dependence) that would induce withdrawal symptoms that would disallow a subject being able to remain substance free for the 7-10-hour psilocybin dosing period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline 1, baseline 2, day 1 post-dose, week 1 post-dose, week 2 post-dose, week 4 post-dose, week 8 post-dose
Awards & highlights

Summary

This trial will investigate if combining a single dose of psilocybin with Vagus Nerve Stimulation can enhance and prolong its antidepressant effects. The study will also look at how psilocy

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, psilocybin may cause changes in perception, mood swings, dizziness or nausea. taVNS might lead to mild discomfort at the stimulation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with major depression for at least 60 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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A close family member has a history of a psychotic disorder.
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I do not have a substance use disorder that would cause withdrawal symptoms during a 7-10 hour period.
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I do not have any medical or psychiatric conditions that would exclude me.
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I cannot or will not stop taking my mental health medications for the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline 1, baseline 2, day 1 post-dose, week 1 post-dose, week 2 post-dose, week 4 post-dose, week 8 post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1, baseline 2, day 1 post-dose, week 1 post-dose, week 2 post-dose, week 4 post-dose, week 8 post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery-Åsberg Depression Rating Scale (MADRS) score
Quality of Life Enjoyment and Satisfaction Questionnaire Short-Form (Q-LES-Q) score
Sheehan Disability Scale (SDS) score
Secondary study objectives
30-item Mystical Experiences Questionnaire (MEQ30) score
Awe Experiences Questionnaire (AWE) score
Challenging Experiences Questionnaire (CEQ) score
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 1: Psilocybin + Treatment as Usual + taVNSExperimental Treatment3 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 UsualActive Control2 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 taVNSPlacebo Group3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Usona InstituteOTHER
15 Previous Clinical Trials
836 Total Patients Enrolled
8 Trials studying Depression
602 Patients Enrolled for Depression
Emory UniversityOTHER
1,679 Previous Clinical Trials
2,583,525 Total Patients Enrolled
61 Trials studying Depression
9,029 Patients Enrolled for Depression
Elaine SandlerLead Sponsor
~94 spots leftby Feb 2029
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