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Recruiting Phase 3 NCT04041479

Biomarker-guided rTMS for Treatment Resistant Depression

Trial Parameters

Condition Treatment Resistant Depression
Sponsor Weill Medical College of Cornell University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 348
Sex ALL
Min Age 22 Years
Max Age 65 Years
Start Date 2021-09-17
Completion 2027-04
Interventions
Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age 22 to 65 years * Major Depressive Disorder (by M.I.N.I., Diagnostic Statistical Manual V (DSM-V criteria)); Verification by evaluation by licensed study psychiatrist or psychologist * At least moderately severe depression (17-item Hamilton Depression Rating Scale greater than or equal to 18) * Failure to respond in the current episode to at least 1 antidepressant medication at an adequate dose and duration as measured by a modified Antidepressant Treatment History Form. The Maudsley Staging Method will also be used to quantify treatment resistance. * Any and all medication intended to treat depression or reduce symptoms of depression must be discontinued or maintained at the same daily dose for ≥ 4 weeks prior to enrollment and for the duration of the study * Capacity to consent * Written consent to allow communication between members of the research team and the patient's outpatient clinician(s) (psychiatrist, psychotherapist, nurse practitioner, primary care

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