RecruitingPhase 3

Biomarker-guided rTMS for Treatment Resistant Depression

Efficacy of Biomarker-guided rTMS for Treatment Resistant Depression

Who can join

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

Age
22 Years to 65 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

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression."
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 tests whether brain scan patterns can help improve rTMS, a depression treatment that uses magnetic pulses. It is for adults ages 22 to 65 whose depression has not improved with medicine. Researchers also want to learn how rTMS changes connections in the brain.

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. The investigators are continuing to learn how to optimize outcomes from rTMS treatment. The purpose of this research project is to use brain network connectivity patterns as measured by resting state functional magnetic resonance imaging (fMRI) to confirm a way to optimize the use of rTMS to treat depression. In addition, the study aims to gain a better understanding of how rTMS influences brain networks.

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

Eligibility

Who can join

  • You are 22 to 65 years old and speak English fluently.
  • A study psychiatrist or psychologist confirms that you have major depression.
  • Your depression is at least moderately severe, based on a symptom rating scale.
  • At least one antidepressant did not help during your current period of depression, despite taking enough medicine for enough time.
  • All medicines for depression must be stopped or kept at the same daily dose for at least 4 weeks before joining and throughout the study.
  • You can understand the study and agree to take part.
  • You give written permission for the study team to contact your usual care providers when needed for safety.
  • You can safely have an MRI brain scan.

Who can't join

  • You are at immediate risk of suicide, or your current period of depression has lasted 2 years or longer.
  • You have a main mental health diagnosis other than major depression, with or without generalized anxiety or a phobia; substance misuse or addiction in the past 12 months, except nicotine; or memory or thinking problems on a test.
  • You started talk therapy within 8 weeks of screening, already had a full course of this study’s TMS treatment during your current depression, or joined a trial of an experimental drug or device within 6 weeks of screening.
  • You had brain surgery for a brain or mental health disorder, have a serious brain or nerve disorder, or have a seizure history or condition or medicine that raises seizure risk. Fever-related seizures in childhood are an exception.
  • You have an electronic implant or metal object in or near your head, or an implant controlled by body signals. You currently receive vagus nerve stimulation, which stimulates a nerve to treat depression, or it did not help you before.
  • You are pregnant, breastfeeding, planning pregnancy during the study, or not using birth control the study doctor considers acceptable.
  • You have a health condition that could prevent you from completing the study, which lasts up to 21 weeks, or abnormal blood tests for body salts, thyroid function, or liver function.
  • You take more than 300 mg of bupropion a day or take a tricyclic antidepressant, a type of depression medicine.

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

Official eligibility criteria

Inclusion Criteria: * Age 22 to 65 years * Major Depressive Disorder (by M.I.N.I., Diagnostic Statistical Manual V (DSM-V criteria)); Verification by evaluation by licensed study psychiatrist or psychologist * At least moderately severe depression (17-item Hamilton Depression Rating Scale greater than or equal to 18) * Failure to respond in the current episode to at least 1 antidepressant medication at an adequate dose and duration as measured by a modified Antidepressant Treatment History Form. The Maudsley Staging Method will also be used to quantify treatment resistance. * Any and all medication intended to treat depression or reduce symptoms of depression must be discontinued or maintained at the same daily dose for ≥ 4 weeks prior to enrollment and for the duration of the study * Capacity to consent * Written consent to allow communication between members of the research team and the patient's outpatient clinician(s) (psychiatrist, psychotherapist, nurse practitioner, primary care physician, or equivalent) as needed to ensure safety * Ability to safely participate in MRI * Fluent in English Exclusion Criteria: * Imminent risk of suicide (based on the Columbia-Suicide Severity Rating Scale) * Current depressive episode greater than or equal to 2 years duration * Presence of primary psychiatric diagnoses other than MDD and/or comorbid generalized anxiety disorder (GAD) or phobia (e.g., post-traumatic stress disorder; obsessive-compulsive disorder; MDD w psychotic features; primary psychotic illness; Bipolar I or II) * DSM-5 defined addiction to, dependence on, abuse of, or misuse of any substance during the prior 12 months, excluding nicotine * Evidence of cognitive impairment (MMSE score falling greater than or equal to 1 SD below the mean score for his or her age and education) * Recent onset (within 8 weeks of screening) psychotherapy, including, but not limited to: any form of treatment, aid, or therapy that has intensively and extensively examined the patient's psychological history, including, but not limited to: cognitive behavioral therapy, dialectical behavioral therapy, interpersonal therapy, and family-focused therapy * Prior exposure to an adequate dose and duration of the TMS treatment protocol administered in this study during the current depressive episode. * Participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening * History of neurosurgery to treat a neurological or psychiatric disorder * Evidence or history of significant neurological disorder, including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor), epilepsy, history of seizures, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors within the central nervous system * Implanted electronic devices and/or conductive objects in or near the head, including metal plates, aneurysm coils, cochlear implants, ocular implants, deep brain stimulation devices and stents * Any implanted device that is activated or controlled in any way by physiological signals, including, but not limited to: deep brain stimulators, cochlear implants, and vagus nerve stimulators * Patients with major depressive disorder who have failed to receive clinical benefit from Vagus Nerve Stimulation (VNS) or are currently receiving these therapies. * History of seizures (except juvenile febrile seizures) or any condition/concurrent medication that could notably lower seizure threshold * Individuals who are pregnant, nursing, contemplating pregnancy within the length of the study or, in the opinion of the investigator, not adherent to a medically acceptable method of birth control * History or presence of any disease, medical condition or physical condition that, in the opinion of the investigator, may compromise, interfere, limit, effect, or reduce the participant's ability to complete a treatment study lasting up to 21 weeks * Abnormal bloodwork for electrolytes, thyroid and liver function * Individuals who are taking \> 300 mg daily dose of bupropion in any formulation (immediate, extended, or slow-release) * Individuals who are taking tricyclic antidepressants.

Study sites (2)

CA

NY