Indianapolis, INNCT06511544Now EnrollingIRB Ready

Depression, Treatment Resistant Clinical Trial in Indianapolis, IN

Access cutting-edge depression, treatment resistant treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Indiana University

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Expert Care in Indianapolis

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related depression, treatment resistant treatment provided free

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Check if you qualify for this depression, treatment resistant clinical trial in Indianapolis, IN

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Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Depression, Treatment Resistant Study in Indianapolis

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

Sponsor: Indiana University

Who Can Participate

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)
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT06511544) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Depression, Treatment Resistant Treatment Options in Indianapolis, IN

If you're searching for depression, treatment resistant treatment options in Indianapolis, IN, this clinical trial (NCT06511544) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced depression, treatment resistant specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all depression, treatment resistant clinical trials near you to find additional studies recruiting in your area.

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