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Mindfulness-based Psilocybin Therapy for PTSD

NCT07104916 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-03

No results posted yet for this study

Summary

The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).

Conditions

  • Post Traumatic Stress Disorder
  • Depression - Major Depressive Disorder

Interventions

COMBINATION_PRODUCT

Psilocybin + MBCT therapy

The experimental arm has psilocybin with support and MBCT sessions.

COMBINATION_PRODUCT

Active Comparator: Psilocybin with Support Only

The active comparator has psilocybin with support only.

Sponsors & Collaborators

  • Anthony P King

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-09-30
Completion
2029-12-31
FDA Drug
Yes

More Related Trials

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 NCT07104916 on ClinicalTrials.gov