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Psilocybin rTMS for Treatment Resistant Depression

NCT06132178 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-26

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

Conditions

Interventions

DRUG

Psilocybin

A psychedelic drug found in certain mushrooms. It will be in a capsule of 25mg psilocybin (COMP360).

DEVICE

Accelerated intermittent theta burst (aiTBS) rTMS treatment

A form of non-invasive brain stimulation that delivers a series of quick magnetic pulses to the scalp and a portion of the brain. It will be targeted to a functional magnetic resonance imaging (fMRI) functional connectivity-guided personalized left dorsolateral prefrontal cortex target using neuronavigation and delivered over 10 sessions daily for 5 consecutive days at 90% of coil-to-target depth-corrected resting motor threshold.

DRUG

Low-dose psilocybin

A psychedelic drug found in certain mushrooms. It will be in a low-dose form of the experimental dose as a 1mg capsule of psilocybin (COMP360).

DEVICE

Sham Accelerated intermittent theta burst (aiTBS) rTMS treatment

The sham version is meant to look and feel like the active SAINT rTMS, but the main difference is that the brain is not being stimulated like the active condition.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Gregory A Fonzo, Ph.D. · The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06132178 on ClinicalTrials.gov