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Procedure
Transcranial Magnetic Stimulation for Depression
N/A
Recruiting
Led By Susan K Conroy, MD PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to consent
Diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by study psychiatrist
Must not have
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)
Prior exposure to any form of TMS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before transcranial magnetic stimulation (tms) - immediately following tms
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using Transcranial Magnetic Stimulation (TMS) on a specific part of the brain can help with rumination in adults with major depression who haven't gotten better with
Who is the study for?
This trial is for adults with major depression that hasn't improved after at least one medication attempt. Participants will undergo brain scans and TMS treatments, and must be able to complete questionnaires and a computer task.
What is being tested?
The study tests if Transcranial Magnetic Stimulation (TMS) targeting the VMPFC part of the brain can reduce rumination in treatment-resistant depression. It measures changes in brain activity and rumination through fMRI scans before, during, and after TMS sessions.
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Most side effects are mild to moderate and improve shortly after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and agree to the study's requirements.
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I have been diagnosed with major depression without psychosis.
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My first depressive episode occurred before I turned 50.
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I am currently experiencing moderate to severe depression.
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My current depression did not improve after trying at least one antidepressant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a mental health condition, but it's not major depression without psychosis.
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I have previously undergone TMS therapy.
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ECT treatments did not work for me.
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I have had brain surgery for a neurological or mental health condition.
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I have not had a serious brain injury, stroke, Parkinson's disease, or similar conditions.
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I have epilepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before tms- immediately following tms
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before tms- immediately following tms
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional Connectivity
Rumination
Secondary study objectives
Overall Depression Scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Active TMSExperimental Treatment1 Intervention
All participants will receive active TMS to the VMPFC for 20 sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial magnetic stimulation
2015
Completed Phase 4
~590
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
375 Previous Clinical Trials
412,799 Total Patients Enrolled
7 Trials studying Depression
1,676 Patients Enrolled for Depression
Indiana UniversityLead Sponsor
1,042 Previous Clinical Trials
1,316,627 Total Patients Enrolled
32 Trials studying Depression
11,864 Patients Enrolled for Depression
Susan K Conroy, MD PhDPrincipal InvestigatorIndiana University School of Medicine