Identifying biomarkers for major depression and treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.