Using brain stimulation to treat severe depression

rTMS Intervention for DMPFC Treatment of Treatment-Resistant Depression Under the Guidance of Personalized Brain Functional Area Dissection (pBFS) Technology

This study is testing a brain stimulation treatment for people with severe depression who haven’t found relief from other therapies, to see if it can help them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 5 sites (Hebei, Baoding and 4 other locations)
• Trial ID: NCT06350396 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled trial investigates the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) targeting the dorsomedial prefrontal cortex (DMPFC) in patients with treatment-resistant depression. The study aims to personalize treatment by utilizing brain functional sector (pBFS) guidance to enhance the therapeutic response. Participants will be randomly assigned to receive either active rTMS or sham treatment over a 21-day period, followed by multiple follow-up assessments to evaluate outcomes. The research seeks to improve clinical efficacy and understanding of depression dimensions through targeted neuromodulation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 65 with a diagnosis of major depressive disorder who have not responded to at least one antidepressant treatment.

Not a fit: Patients with psychiatric symptoms other than depression or those who have not met the criteria for treatment-resistant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: Previous studies have shown promising results with rTMS for depression, but this specific approach targeting the DMPFC is relatively novel.

Eligibility criteria

Inclusion Criteria:

* (1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and are not accompanied by psychiatric symptoms, with single or repeated episodes;
* (2) The Hamilton Depression Scale (HAMD) score for 17 items before randomization was ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score was ≥ 20 points;
* (3) Individuals aged ≥ 18 and ≤ 65 years old, regardless of gender;
* (4) Currently, at least one antidepressant has been used for 6 weeks and the dosage used cannot be lower than the prescribed range of drug use;
* (5) The Maudsley Staging Method (MSM) assesses patients as having at least moderate refractory levels (MSM score ≥ 7);
* (6) Before randomization, the current antidepressant treatment regimen should be stable for at least 4 weeks, and the dosage used should not be lower than the prescribed range of drug use;
* (7) Having received education for 5 years or more;
* (8) Understand the experiment and sign an informed consent form.

Exclusion Criteria:

* (1) Meets the DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or depression caused by other medical issues;
* (2) Individuals with pacemakers, cochlear implants, or other metal foreign objects, as well as any electronic devices implanted in the body, contraindications for magnetic resonance imaging scans such as claustrophobia, and contraindications for rTMS treatment;
* (3) Concomitant history of epilepsy (with at least 2 non induced seizures with an interval of more than 24 hours, diagnosed with epilepsy syndrome, or having seizures within the past 12 months);
* (4) Individuals who have received modified electroconvulsive mECT, rTMS, or light therapy within 3 months;
* (5) Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
* (6) Complicated with serious heart, liver, kidney diseases, diabetes and other serious physical diseases;
* (7) Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
* (8) Have a history of drug and alcohol abuse within the past year;
* (9) First degree relatives suffer from bipolar disorder;
* (10) There is a significant risk of suicide (the 10th item of the MADRS scale is ≥ 5 points);
* (11) Difficulty in verbal communication to the point of being unable to communicate normally, understand or follow instructions, and unable to cooperate with treatment and evaluation;
* (12) Currently participating in clinical trials of other drugs or physical therapies (such as deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS);
* (13) The researchers believe it is not suitable to participate.

Where this trial is running

Hebei, Baoding and 4 other locations

• Hebei Mental Health Center — Hebei, Baoding, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, China (Not_yet_recruiting)
• Inner Mongolia Mental Health Center — Hohhot, China (Recruiting)
• Shandong Daizhuang Hospital — Jining, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xinxiang Medical University — Xinxiang, China (Recruiting)

Study contacts

• Study coordinator: Meiling Li, Ph.D.

Conditions Treatment Resistant Depression; Major Depressive Disorder; Major Depression, Moderate Depression, MDD; personalized neuromodulation; Personalized Brain Functional Sectors