Using targeted brain stimulation to treat treatment-resistant depression
Personalized Brain Functional Sector-guided rTMS Therapy Targeting DMPFC for Treatment-resistant Depression
This study is testing a new brain stimulation treatment for people with depression that hasn't improved with other therapies to see if it can help them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 3 sites (Baoding, Hebei and 2 other locations) |
| Trial ID | NCT05948839 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of personalized brain functional sector (pBFS)-guided repetitive transcranial magnetic stimulation (rTMS) therapy aimed at the dorsomedial prefrontal cortex (DMPFC) for patients suffering from treatment-resistant depression. Participants will be randomized into either an active rTMS group or a sham-control group after a screening period. The study will involve a 21-day rTMS modulation followed by follow-up visits at three and nine weeks. The goal is to improve clinical treatment efficacy by tailoring the intervention based on individual brain function.
Who should consider this trial
Good fit: Ideal candidates are hospitalized or outpatient adults aged 18-65 with a diagnosis of major depressive disorder who have not responded adequately to previous antidepressant treatments.
Not a fit: Patients with other mental disorders such as schizophrenia or bipolar disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results with rTMS targeting the DMPFC, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 HAMD17 score ≥20 and total MADRS score ≥25 before randomization. * Inadequate response to at least one antidepressant trial of adequate doses and duration. * A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization. * Voluntarily participate in the trial and sign 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 planning 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. * First-degree relatives have bipolar affective disorder. * There is a significant risk of suicide (MADRS item 10 ≥ 5). * Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators. * Investigators think that was inappropriate to participate.
Where this trial is running
Baoding, Hebei and 2 other locations
- Hebei Mental Health Center — Baoding, Hebei, China (Recruiting)
- Shandong Daizhuang Hospital — Jining, China (Recruiting)
- The Second Affiliated Hospital of Xinxiang Medical University — Xinxiang, China (Recruiting)
Study contacts
- Study coordinator: Meiling Li, Ph.D.
- Email: meilingli@cpl.ac.cn
- Phone: 010-80726688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.