Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT04581902

Biomarkers of Depression and Treatment Response

Led by University of California, San Francisco · Updated on 2026-01-30

50

Participants Needed

1

Research Sites

352 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarkers of Depression and Treatment Response

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-70
  • Diagnosed with Major Depressive Disorder in a current major depressive episode without psychotic features
  • Montgomery-Asberg Depressive Rating Scale (MADRS) score greater than 19 at baseline indicating moderate to severe depression
  • Moderate resistance to antidepressant treatment in the current episode, defined as failure of 1-4 adequate medication trials
  • No changes to psychotropic medication regimen between pre-treatment and post-treatment scans if currently taking medication
  • Willing and able to undergo non-invasive brain stimulation
  • Willing and able to attend research visits for approximately 8 weeks
  • Able to provide informed consent
  • Able to speak and read English
Not Eligible

You will not qualify if you...

  • Diagnosis of acute or chronic psychotic symptoms or psychotic disorders during the current depressive episode
  • Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of severe head trauma, or brain tumors
  • Presence of implanted magnetic-sensitive medical devices near the head (e.g., pacemaker, vagus nerve stimulator, metal clips, coils, staples, or stents)
  • Generalized anxiety disorder as the primary diagnosis during the current MDD episode
  • Alcohol or substance abuse or dependence (other than caffeine) within the past 6 months
  • History of seizures
  • Implantable hardware not compatible with MRI or study requirements
  • Inability to comply with daily study visits
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Inability to speak and/or read English
  • Inability to give informed consent
  • Active suicidal intent or plan during the current episode as determined by standardized assessments or clinical judgment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

K

Katherine Scangos, MD, PhD

CONTACT

R

Rebecca Martinez, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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