Who is eligible for clinical trial NCT06511544?

Participants must meet protocol criteria for Depression, Treatment Resistant. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06511544 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-24

rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression (NCT06511544)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Indiana University

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (18 items).

Location: Goodman Hall Neuroscience Center — Indianapolis, Indiana

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Goodman Hall Neuroscience Center — Indianapolis, Indiana

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗