Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID04581902

Biomarkers of Depression and Treatment Response Using Multimodal Imaging and rTMS Therapy

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

50

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying Major Depressive Disorder (MDD) to identify biomarkers that can help diagnose the condition and predict how patients respond to treatment. This study uses multimodal imaging and electrophysiological methods to monitor changes during a course of transcranial magnetic stimulation (TMS) therapy. The goal is to find reliable measures that can improve clinical care and personalize treatment for depression. Participants will undergo initial screening and baseline assessments including resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), and electroencephalography (EEG) scans before starting TMS. They will receive 30 to 40 daily sessions of repetitive TMS (rTMS) to the dorsolateral prefrontal cortex, with scans repeated midway and after treatment to observe changes. Treatment parameters are set by TMS providers, typically involving 10 Hz stimulation at 120% motor threshold. During the study, participants will be closely monitored with clinical evaluations and imaging scans before, during, and after the approximately 8-week treatment period. Outcomes measured include changes in depression severity using the MADRS scale, brain activity and structure from imaging and EEG, and other depression and anxiety rating scales. Safety and treatment response will be tracked throughout to understand the neural effects of TMS and improve future care.

CONDITIONS

Brief 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 to 70 years
  • 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
  • Moderate resistance to antidepressant treatment defined as failure of 1 to 4 adequate medication trials
  • Stable psychotropic medication regimen with no changes during pre- and post-treatment scans
  • 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
  • Ability to speak and read English
Not Eligible

You will not qualify if you...

  • Diagnosis of acute or chronic psychotic symptoms during current depressive episode
  • Neurological conditions such as epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, 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, stents)
  • Generalized anxiety disorder as the primary diagnosis during current MDD episode
  • Alcohol or substance abuse or dependence (except caffeine) within past 6 months
  • History of seizures
  • Implantable hardware incompatible with MRI or study procedures
  • Unable to comply with daily study visits
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Inability to speak or read English
  • Unable to provide informed consent
  • Active suicidal intent or plan during current depressive episode as determined by clinical assessments or Beck's Depression Inventory question #9 score of 3 or clinician judgment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 8 weeks

Participants complete 30 to 40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) therapy to the dorsolateral prefrontal cortex (DLPFC). EEG and MRI scans are performed before treatment, at treatment midpoint, and within one month after treatment to track brain changes over the course of therapy.

30 to 40 daily visits for rTMS treatment, plus 3 imaging visits

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

R

Rebecca Martinez, MS

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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