Recruiting
Biomarkers of Depression and Treatment Response
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.
ClinicalTrials.gov IDNCT04581902
PhaseNA
Enrollment50
SponsorUniversity of California, San Francisco
Age18 Years
SexALL
Conditions studied
Depressive Disorder, Major
About this study
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.
Interventions
- Device: 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 outcomes
- Change in MADRS score from baseline to end of treatment (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 (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 (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 (Up to one month prior to initial TMS session (baseline) to within one month following the completion of TMS treatment (~ 8 weeks))
Eligibility information
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 locations
- University of California, San Francisco, San Francisco, California 94143 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.