NCT04581902 Biomarkers of Depression and Treatment Response
| NCT ID | NCT04581902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-12-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Andrew Krystal, MD, MS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04581902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04581902 currently recruiting?
Yes, NCT04581902 is actively recruiting participants. Contact the research team at brainstim@ucsf.edu for enrollment information.
Where is the NCT04581902 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04581902 clinical trial?
NCT04581902 is sponsored by University of California, San Francisco. The principal investigator is Andrew Krystal, MD, MS at University of California, San Francisco. The trial plans to enroll 50 participants.