Actively Recruiting

Phase 2
Age: 22Years - 65Years
All Genders
NCT06132178

Psilocybin rTMS for Treatment Resistant Depression

Led by University of Texas at Austin · Updated on 2025-11-26

100

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Psilocybin rTMS for Treatment Resistant Depression

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults, ages 22-65
  • Able to understand and speak English to follow instructions and communicate with study staff
  • Diagnosed with current major depressive episode lasting at least 3 months (recurrent or single episode MDD)
  • Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or higher at baseline
  • Treatment-resistant MDD, defined as failure to respond to adequate dose and duration of two or more antidepressant treatments
  • Willing and able to attend daily full-day visits for about 2 weeks and participate in all study procedures
  • If on antidepressants or related medications, willing to discontinue them with study support and remain off for specified periods before and after baseline visit
Not Eligible

You will not qualify if you...

  • History or current diagnosis of psychotic disorder, bipolar disorder, or personality disorder
  • Current diagnosis of PTSD, acute stress disorder, OCD, anorexia nervosa, bulimia nervosa, or substance-use disorder
  • Substance-use disorder within the past year
  • Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during current depressive episode
  • Prior rTMS treatment
  • Currently in psychotherapy for major depression (except stable supportive psychotherapy)
  • Significant suicide risk within past 12 months or at screening
  • Major depressive episode secondary to medication or medical condition
  • Major medical conditions or unstable life circumstances interfering with participation
  • Past-year use of serotonergic psychedelics or more than 5 lifetime uses
  • Unwilling to avoid additional serotonergic psychedelics during study follow-up
  • Ferrous metal implants or devices incompatible with rTMS or MRI
  • History of seizures, epilepsy, neurological disorders, or significant head injury
  • Recent head injury within 2 months
  • Pregnant or nursing
  • Not using effective contraception if sexually active
  • Severe claustrophobia
  • Uncontrolled hypertension or thyroid disease
  • Significant heart conditions or abnormal ECG
  • Type I diabetes or uncontrolled Type II diabetes
  • Positive drug screen for substances of abuse
  • Clinically significant abnormalities in physical exams or lab tests
  • Participation in another interventional study within 6 months
  • Hypersensitivity to psilocybin or serotonergic psychedelics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Austin, Texas, United States, 78712

Actively Recruiting

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Research Team

L

Lauren K Enten, B.S.A.

CONTACT

G

Gregory A Fonzo, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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