RecruitingPhase 2NCT06132178

Psilocybin rTMS for Treatment Resistant Depression

Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder


Sponsor

University of Texas at Austin

Enrollment

100 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial combines two treatments — psilocybin (a psychedelic compound from mushrooms, used under medical supervision) and repetitive transcranial magnetic stimulation (rTMS, a non-invasive brain stimulation technique) — for people with treatment-resistant depression. The goal is to see whether this combination can help people whose depression has not responded to multiple medications. **You may be eligible if...** - You are 22 to 65 years old - You have moderate-to-severe major depressive disorder that has not responded to at least 2 antidepressant medications - You do not have psychotic features with your depression - You are willing to taper off antidepressants before the study - You are willing to attend daily sessions at the research site for about 2 weeks **You may NOT be eligible if...** - You have bipolar disorder, psychosis, PTSD, or an eating disorder - You have had a seizure or have epilepsy - You have metal implants in your head (such as a brain stimulator or cochlear implant) - You are pregnant or planning to become pregnant - You have significant active suicidal intent - You have used a serotonergic psychedelic (like LSD or psilocybin) in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

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

DEVICEAccelerated 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.

DRUGLow-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).

DEVICESham 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.


Locations(1)

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600

Austin, Texas, United States

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NCT06132178


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