Recruiting

Biomarkers of Depression

Sponsor:

UCLA

Code:

NCT04581902

Conditions

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

rTMS therapy

Study Details

Brief 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.

Conditions

Depressive Disorder, Major

Study ID

NCT04581902

Start date

Dec 1, 2020

Status verified date

Jan, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-70
  • Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.
  • Has Montgomery-Asberg Depressive Rating Scale (MADRS) of > 19 at baseline, corresponding with moderate to severe depression.
  • Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.
  • If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which pre-treatment and post-treatment scans are taken.
  • Willing and able to undergo non-invasive brain stimulation
  • Willing and able to attend research visits for approximately 8 weeks
  • Willing and able to provide informed consent
  • Ability to speak and read English

Exclusion Criteria:

  • Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.
  • Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
  • Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.
  • Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.
  • Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID
  • History of seizures
  • Implantable hardware not compatible with MRI or with the study
  • Inability to comply with study daily visits
  • Women who are pregnant, plan to become pregnant, or breast feeding
  • Inability to speak and/or read English
  • Inability to give consent
  • Any active suicidal intent or plan during the current depressive episode, as determined by a score of 3 on Question #9 of Beck's Depression Inventory (scores reviewed daily by study team members versed in scoring clinical scales), or as by a subjective determination by a study clinician during any study visit.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Morning rTMS treatment

Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.

experimental: Afternoon rTMS treatment

Eligible participants will be assigned to the afternoon treatment group. Prior to the onset of rTMS treatment, EEG scans and magnetic resonance imaging (MRI) sessions including diffusion weighted imaging will be recorded as baseline measures. These measures will also be repeated at treatment midpoint and within one month of rTMS discontinuation in order to track structural and functional changes that occur over the course of treatment. Participants will complete an initial screening followed by 30-40 daily sessions of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC), completed with their TMS provider.

Interventions

rTMS 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.

Primary outcome measure

  • Change in MADRS score from baseline to end of treatment [ Time Frame: Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks) ]
  • Change in resting state BOLD signal from baseline to end of treatment [ Time Frame: Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks) ]
  • Change in resting state EEG from baseline to end of treatment [ Time Frame: Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks) ]
  • Change in white matter integrity from baseline to end of treatment [ Time Frame: Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks) ]

Central Contacts and Locations

Central contacts

Katherine Scangos, MD, PhD

415-476-7439brainstim@ucsf.edu

Rebecca Martinez, MS

rebecca.martinez@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Katherine Scangos, MD, PhD

415-476-7439trdepression@ucsf.edu

Rebecca Martinez, MS

415- 514-6489rebecca.martinez@ucsf.edu

Principal Investigator:

Katherine Scangos, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • transcranial magnetic stimulation
  • depression
  • biomarker
  • TMS
  • neuroimaging
  • rTMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-30.