Skip to content
lsd.com
Active, not recruitingPhase 1

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

NCT03554174 · Yale University

Closed to entry
Status
Not accepting participants
Phase 1
Phase
18
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)

    Measured over One day and two weeks after each experimental session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE) * Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode * Currently engaged in treatment with a mental health clinician Exclusion Criteria: * Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis) * Axis I psychotic disorder in first degree relative * Currently taking a conventional antidepressant medication * Unstable medical or neurological conditions * Significant cognitive disorders * History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc. * Pregnant, breastfeeding, lack of adequate birth control * Urine toxicology positive to drugs of abuse on experimental test days

Where

1 study site

FacilityCityRegionCountry
VA Connecticut Healthcare System, West Haven CampusWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03554174 on ClinicalTrials.gov →

Last updated in the registry 2025-11-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 49 trials from Yale University →