Actively Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Led by Indiana University · Updated on 2025-09-29
20
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unipolar major depressive disorder without psychotic features confirmed by Mini-International Neuropsychiatric Interview and study psychiatrist
- First depressive episode occurred before age 50
- Current moderate to severe depression with Hamilton Depression Rating Scale score of 17 or higher
- Failure to respond to at least one antidepressant medication trial at adequate dose and duration in the current episode
- Off psychotropic medications or on stable doses for at least 6 weeks and willing to maintain stable dosage during the study
- Capacity to consent and ability to safely receive MRI
You will not qualify if you...
- Actively or imminently suicidal with Quick Inventory of Depressive Symptomatology item 12 score greater than 2
- Current depressive episode lasting more than 5 years
- Presence of significant psychiatric diagnoses other than unipolar non-psychotic major depression such as PTSD or OCD
- Cognitive impairment with Montreal Cognitive Assessment score below 23
- Significant substance use disorder within past 6 months
- New psychotherapy or somatic therapy within 6 weeks of screening
- Previous exposure to any form of TMS
- Participation in clinical trial with investigational drug or device within 6 weeks prior to screening
- Failure to respond to Electroconvulsive Therapy
- History of neurosurgery for neurologic or psychiatric disorders
- Unstable medical illness
- History or evidence of significant neurological disorders including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorders except benign essential tremor
- Epilepsy or history of seizures except juvenile febrile seizures or provoked seizures at investigator discretion
- Pregnancy or planned pregnancy during the study
- Presence of cardiac pacemaker, cochlear implant, or other implanted electronic devices
- Vision problems preventing seeing adjectives inside MRI scanner without glasses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Goodman Hall Neuroscience Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
S
Susan K Conroy, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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