Actively Recruiting

Phase 3
Age: 22Years - 65Years
All Genders
NCT04041479

Biomarker-guided rTMS for Treatment Resistant Depression

Led by Weill Medical College of Cornell University · Updated on 2026-02-25

348

Participants Needed

2

Research Sites

306 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. The investigators are continuing to learn how to optimize outcomes from rTMS treatment. The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression. In addition, the study aims to gain a better understanding of how rTMS influences brain networks.

CONDITIONS

Official Title

Biomarker-guided rTMS for Treatment Resistant Depression

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 22 to 65 years
  • Diagnosis of Major Depressive Disorder based on DSM-V criteria confirmed by a licensed psychiatrist or psychologist
  • At least moderately severe depression with a Hamilton Depression Rating Scale score of 18 or higher
  • Failure to respond to at least one adequate dose and duration of antidepressant medication during the current depressive episode
  • All medications for depression must be stable or discontinued for at least 4 weeks before enrollment and during the study
  • Ability to provide informed consent
  • Written consent to allow communication between research team and outpatient clinicians for safety
  • Ability to safely undergo MRI
  • Fluent in English
Not Eligible

You will not qualify if you...

  • Imminent risk of suicide as assessed by Columbia-Suicide Severity Rating Scale
  • Current depressive episode lasting 2 years or longer
  • Primary psychiatric diagnoses other than MDD or comorbid generalized anxiety disorder or phobia
  • Substance addiction, dependence, abuse, or misuse (excluding nicotine) within the past 12 months
  • Cognitive impairment as indicated by MMSE score 1 SD below the mean for age and education
  • Psychotherapy started within 8 weeks prior to screening
  • Prior exposure to the specific TMS protocol used in this study during current depressive episode
  • Participation in any clinical trial with investigational drug or device within 6 weeks before screening
  • History of neurosurgery for neurological or psychiatric disorders
  • Significant neurological disorders including moderate to severe head trauma, stroke, Parkinson's disease, epilepsy, seizures, cerebrovascular disease, dementia, increased intracranial pressure, or brain tumors
  • Implanted electronic or conductive devices near the head, including deep brain stimulators, cochlear implants, and stents
  • Patients who have not benefited from or currently use Vagus Nerve Stimulation
  • History of seizures (except juvenile febrile seizures) or conditions/medications lowering seizure threshold
  • Pregnant, nursing, planning pregnancy during the study, or non-adherent to birth control
  • Any medical or physical condition that may interfere with completing the study lasting up to 21 weeks
  • Abnormal blood tests for electrolytes, thyroid, or liver function
  • Taking over 300 mg daily of bupropion
  • Taking tricyclic antidepressants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

2

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

M

Megan Johnson

CONTACT

L

Lindsay Victoria, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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