Actively Recruiting
Efficacy of 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
17 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
Researchers are investigating the use of repetitive transcranial magnetic stimulation (rTMS) to treat patients with treatment-resistant depression, a condition where standard antidepressant medications have failed. This study aims to confirm whether a new approach using brain connectivity patterns measured by resting state functional MRI (fMRI) can improve how rTMS is targeted to different brain areas for better outcomes. The study also seeks to understand how rTMS affects brain networks in these patients. Participants will be randomly assigned to one of three groups: one receiving standard rTMS targeting the left dorsolateral prefrontal cortex (DLPFC), another receiving rTMS targeted to the brain area predicted to be most effective for their depression subtype based on brain imaging (either DLPFC or dorsomedial prefrontal cortex, DMPFC), and a third group receiving rTMS targeting the opposite brain area than predicted. The treatment uses intermittent theta burst stimulation (iTBS) delivered at 120% of the resting motor threshold in short bursts totaling about 3 minutes per session. Throughout the study, participants will undergo brain scans, behavioral tests, and clinical assessments before and after the treatment period of 7 to 10 weeks. The main measure of success is the change in depression severity using a standard rating scale. Researchers will also monitor changes in brain connectivity and other depression symptom scores. Safety and treatment effects will be closely observed during the trial, which lasts up to 21 weeks including follow-up.
CONDITIONS
Brief Title
Biomarker-guided rTMS for Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 65 years
- Diagnosis of Major Depressive Disorder confirmed by a licensed psychiatrist or psychologist using DSM-V criteria
- At least moderately severe depression (Hamilton Depression Rating Scale score of 18 or higher)
- Failure to respond to at least one antidepressant medication during the current depressive episode
- Stable or discontinued depression-related medications for at least 4 weeks prior to enrollment and during the study
- Capacity to consent and agree to communication between research team and outpatient clinicians
- Ability to safely participate in MRI
- Fluent in English
You will not qualify if you...
- Imminent risk of suicide
- Current depressive episode lasting 2 years or longer
- Primary psychiatric diagnoses other than Major Depressive Disorder or certain comorbid anxiety disorders
- Substance misuse or addiction (excluding nicotine) within the past 12 months
- Evidence of cognitive impairment
- Recent start of intensive psychotherapy within 8 weeks
- Prior adequate exposure to the rTMS treatment protocol used in this study during current episode
- Participation in another clinical trial with investigational drug or device within 6 weeks
- History of neurosurgery for neurological or psychiatric disorders
- Significant neurological disorders or history increasing seizure risk
- Implanted electronic or conductive devices near the head
- Failure to benefit from or current use of Vagus Nerve Stimulation therapy
- Pregnancy, nursing, or not using acceptable birth control
- Medical conditions that may limit ability to complete the study
- Abnormal blood tests for electrolytes, thyroid or liver function
- Use of high-dose bupropion or tricyclic antidepressants during the study period
- History of seizures except juvenile febrile seizures or medications lowering seizure threshold
- Other conditions judged by the investigator to interfere with study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 9 weeks
Participants receive repetitive transcranial magnetic stimulation (rTMS) targeting either the left dorsolateral prefrontal cortex (DLPFC) or the dorsomedial prefrontal cortex (DMPFC) based on random assignment to one of three study arms.
Daily visits for up to 9 weeks
Duration - Up to 1 week post treatment
After completing treatment, participants are assessed for changes in depression symptoms and brain connectivity using clinical scales and fMRI scans.
1 visit (in-person)
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
Research Team
M
Megan Johnson
L
Lindsay Victoria, PhD
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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