NCT06511544 rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
| NCT ID | NCT06511544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Depression, Treatment Resistant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-01-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main question it aims to answer are: Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? Researchers will compare brain scans and rumination scores before, during, and immediately after TMS. Participants will: Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task
Eligibility Criteria
Inclusion Criteria: * Diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by study psychiatrist * First depressive episode prior to age 50 * Current moderate to severe depression, Hamilton Depression Rating Scale (HDRS) ≥17) * Failure to respond to ≥1 antidepressant medication at adequate dose and duration in the current depressive episode; (note: this criterion is designed to be consistent with the original 2008 FDA-labeled indication for TMS in Major Depressive Disorder, that specifies failure to respond to "one prior medication at or above the minimal effective dose and duration in the current episode" (https://www.accessdata.fda.gov/cdrh\_docs/pdf8/K083538.pdf). )) * Off psychotropic medications OR on a stable dose of medication(s) for 6 weeks, and willing to remain on stable medication dosage throughout the study * Capacity to consent * Ability to safely receive MRI Exclusion Criteria: * Actively/imminently suicidal, Quick Inventory of Depressive Symptomatology (QIDS) item 12 score \>2) * Current depressive episode duration \> 5 years * Presence of clinically significant psychiatric diagnoses other than unipolar, non-psychotic major depression, such as post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder (OCD) * Evidence of cognitive impairment, Montreal Cognitive Assessment (MOCA) \< 23) * Significant substance use disorder within past 6 months * New-onset psychotherapy and/or somatic therapy (e.g., light therapy) within 6 weeks of screening * Prior exposure to any form of TMS * Have participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening * Failure to respond to Electroconvulsive therapy (ECT) * Any history of neurosurgery to treat a neurologic or psychiatric disorder (e.g. Vagus nerve stimulation, cortical stimulation, deep brain stimulation, or ablative surgery) * Unstable medical illness * Evidence or history of significant neurological disorder, including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor) * Epilepsy * History of seizures (except juvenile febrile seizures or provoked seizures at the PI's discretion) or any condition/concurrent medication that could notably lower seizure threshold * Pregnancy or planned pregnancy during the study * Presence of cardiac pacemaker, cochlear implant, or other implanted electronic device * Any vision problem that will prevent them from seeing the adjectives presented inside the MRI scanner without glasses
Contact & Investigator
Susan K Conroy, MD PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06511544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Depression, Treatment Resistant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511544 currently recruiting?
Yes, NCT06511544 is actively recruiting participants. Contact the research team at sconroy@iu.edu for enrollment information.
Where is the NCT06511544 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06511544 clinical trial?
NCT06511544 is sponsored by Indiana University. The principal investigator is Susan K Conroy, MD PhD at Indiana University. The trial plans to enroll 20 participants.
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