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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

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 weeks3 visits

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

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

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

2023

N/A

~50

Psilocybin

2021

Completed Phase 2

~530