Finding the best dosage of rTMS for treating major depression
The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial
This study is testing different doses of a brain stimulation treatment to see if fewer sessions can help people with moderate to severe depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05842278 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal dosage of personalized brain-focused stimulation (pBFS) guided repetitive transcranial magnetic stimulation (rTMS) for patients suffering from moderate to severe depression. Participants aged 18-65 who meet specific diagnostic criteria will be randomized into groups receiving different dosages of rTMS or a sham treatment. The study aims to determine if fewer sessions than the standard 10 per day can still effectively alleviate depressive symptoms, potentially reducing treatment costs and time. Following a 5-day treatment period, participants will be monitored for response and remission over four and eight weeks.
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 adequately responded to previous antidepressant treatments.
Not a fit: Patients with other mental disorders or those currently experiencing psychotic symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and cost-effective treatment option for patients with major depression.
How similar studies have performed: Other studies have shown promise with rTMS for depression, but this specific dosage optimization approach is relatively novel.
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 before randomization. * Total MADRS score of ≥25 before randomization. * Inadequate response to at least one antidepressant trial of adequate doses and duration. * Participants currently are on a stable or no-drug use for at least 4 weeks before randomization. The type and dose of antidepressant drugs remained unchanged throughout the intervention period. * 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
Beijing, Beijing
- Beijing HuiLongGuan Hospital — Beijing, Beijing, 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.