Identifying biomarkers for major depression and treatment response
Biomarkers of Depression and Treatment Response
This study is trying to find specific brain markers that can help identify major depression and how well people respond to a new therapy called TMS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04581902 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers for Major Depressive Disorder (MDD) and treatment response using advanced imaging techniques. Participants will undergo a series of neuroimaging scans, including fMRI, DTI, and EEG, before and after receiving transcranial magnetic stimulation (TMS) therapy. The study will explore previously identified biomarkers and seek new ones by analyzing brain activity and structure changes throughout the treatment process. The goal is to enhance clinical diagnosis and personalize treatment options for individuals with MDD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who meet the criteria for Major Depressive Disorder and have shown resistance to antidepressant treatments.
Not a fit: Patients with acute or chronic psychotic symptoms or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with major depression.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for depression, but this approach utilizing multimodal imaging in conjunction with TMS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Krystal, MD, MS — University of California, San Francisco
- Study coordinator: Katherine Scangos, MD, PhD
- Email: brainstim@ucsf.edu
- Phone: 415-476-7439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.