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Biomarkers of Depression and Treatment Response

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for signs in brain scans and brain activity that may help doctors identify major depression and measure how well treatment works. It is for adults ages 18–70 whose depression has not improved after 1–4 medication trials. Researchers track brain changes during transcranial magnetic stimulation (TMS), a treatment that uses magnets to stimulate the brain without surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–70 years old.
  • Have a current episode of major depression without psychosis, such as seeing or hearing things that are not there.
  • Have moderate to severe depression, with a score above 19 on the MADRS depression scale.
  • Have tried 1–4 antidepressant treatments at adequate doses and lengths of time without success during this episode.
  • If taking mental health medicines, keep them unchanged between the scans before and after treatment.
  • Be willing and able to have brain stimulation without surgery.
  • Be willing and able to attend study visits for about 8 weeks.
  • Be able to speak and read English and give informed consent, meaning you understand and agree to join.

Who can't join

  • Have psychotic symptoms during the current depression episode, or have generalized anxiety disorder as your main mental health condition.
  • Have a history of seizures or certain brain or nerve conditions, including epilepsy, brain blood vessel disease, dementia, high pressure inside the skull, repeated or severe head injuries, or brain or spinal cord tumors.
  • Have a medical device near the head that is affected by magnets, or implanted hardware that is not safe for MRI scans or this study.
  • Have had alcohol or drug abuse or dependence in the past 6 months, except caffeine.
  • Be unable to attend daily study visits.
  • Be pregnant, planning to become pregnant, or breastfeeding.
  • Be unable to speak or read English or give consent.
  • Have any current intent or plan to end your life during this depression episode, based on a depression questionnaire or a study clinician’s judgment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA