RecruitingNot ApplicableNCT04581902

Biomarkers of Depression and Treatment Response


Sponsor

University of California, San Francisco

Enrollment

50 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain imaging and biological tests to understand why some people with major depression respond to treatment and others don't. Participants will receive non-invasive brain stimulation therapy and have brain scans taken before and after treatment to identify markers of response. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with major depressive disorder (MDD) and are currently in a depressive episode without psychotic features - Your depression is moderate-to-severe (MADRS score above 19) - You have tried 1–4 antidepressant medications in this episode without full relief - You are willing to undergo non-invasive brain stimulation and attend visits for about 8 weeks - You can read and speak English **You may NOT be eligible if...** - You have a current psychotic disorder (e.g., schizophrenia) - You have a neurological condition such as epilepsy, dementia, or a history of significant head trauma - You have a metal implant in or near your head (e.g., pacemaker, aneurysm clips) - You have a primary diagnosis of generalized anxiety disorder during this episode - You have had a seizure - You have a current substance use disorder (within the past 6 months) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICErTMS therapy

rTMS treatment parameters will be determined by TMS care providers. Typical TMS settings for MDD involve rTMS applied at 10 Hz with an intensity of 120 % of resting motor threshold. Forty trains of 4 s duration with 11s of trains is typically applied (3000 pulses per day), resulting in approximately 90,000 pulses in a given treatment course.


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT04581902


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