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Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

NCT03554174 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Low Dose Psilocybin

0.1 mg/kg psilocybin capsule

DRUG

Placebo

microcrystalline cellulose capsule

DRUG

Medium Dose Psilocybin

0.3 mg/kg psilocybin capsule

Sponsors & Collaborators

  • Heffter Research Institute

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Deepak D'Souza, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2021-07-08
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554174 on ClinicalTrials.gov