Using different doses of neuromodulation to treat treatment-resistant depression

The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Treatment-resistance Depression： a Randomized， Double-Blind， Sham-controlled Trial

This study is testing different doses of a brain stimulation treatment to see if it can help adults with severe depression feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (other)
• Locations: 2 sites (Zhumadian, Henan and 1 other locations)
• Trial ID: NCT06112652 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of varying doses of repetitive transcranial magnetic stimulation (rTMS) guided by personalized brain function stimulation (pBFS) technology in patients with moderate to severe depressive disorders. Participants aged 18-65 will be randomized into groups receiving different rTMS pulse doses or a sham control. The treatment consists of a 5-day rTMS regimen followed by follow-up visits at four and eight weeks. The goal is to determine the optimal dosage that can effectively alleviate depressive symptoms while potentially reducing treatment costs.

Who should consider this trial

Good fit: Ideal candidates are hospitalized or outpatient adults aged 18-65 with moderate to severe depression who have not responded adequately to previous treatments.

Not a fit: Patients with psychotic symptoms or those not meeting the diagnostic criteria for depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and cost-efficient treatment option for patients with treatment-resistant depression.

How similar studies have performed: Previous studies have shown promise with rTMS for depression, but this specific approach of varying doses guided by pBFS is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
* Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.
* Total HAMD-17 score ≥20 and MADRS ≥20 before randomization.
* The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
* Participants currently are on stable drug use for at least 4 weeks before randomization. Antidepressants used are selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Combined use of two types of antidepressants is allowed.
* Voluntarily participate in the trial and able to provide informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.

Exclusion Criteria:

* Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
* Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
* Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
* History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
* History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
* Currently receiving or plan to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial;
* Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
* Female of childbearing potential who plans to become pregnant during the trial.
* Female that is pregnant or breastfeeding.
* Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
* Investigators think that was inappropriate to participate.

Where this trial is running

Zhumadian, Henan and 1 other locations

• Lei He — Zhumadian, Henan, China (NOT_YET_RECRUITING)
• Wuhan Mental Health Center — Wuhan, China (RECRUITING)

Study contacts

• Study coordinator: Meiling Li, Ph.D.

Conditions: Moderate Depression, Major Depressive Disorder, Severe Depression, transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation