BridgeMD
New treatment option for Depression, Treatment Resistant
Official title rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT06511544
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI) and confirmed...
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.