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Psilocybin-Assisted Therapy in Treatment-Resistant Depression

NCT06303739 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:

* Does psilocybin with assisted therapy help improve symptoms for people with depression?
* How long do the effects of this treatment last?

Participants will:

* Take part in a couple of screening and preparation visits.
* Be given psilocybin in one or two treatment sessions.
* Attend a series of follow-up sessions over the following year.
* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.

Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.

Conditions

Interventions

DRUG

psilocybin

25mg of psilocybin administered during treatment session, accompanied by preparation before, integration after, and assistive therapy during the session.

Sponsors & Collaborators

  • Foundation of Hope, North Carolina

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Robert K McClure, MD · Director of Interventional Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-04-09
Completion
2027-03-26
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 NCT06303739 on ClinicalTrials.gov