High-dose rTMS therapy for treatment-resistant depression
Personalized Brain Functional Sectors (pBFS) Guided High-dose rTMS Therapy for Treatment-resistant Depression: A Randomized, Double-Blind, Sham-controlled Trial
This study is testing if a new way of giving high-dose brain stimulation therapy can help people with depression who haven’t found relief from other treatments, by seeing if shorter breaks between sessions make a difference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Changping Laboratory Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05842291 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of pBFS-guided high-dose repetitive transcranial magnetic stimulation (rTMS) therapy with a short inter-session interval for patients suffering from treatment-resistant depression. The trial involves randomizing participants into groups receiving either active rTMS with short or long inter-session intervals or a sham treatment. The goal is to determine if a shorter waiting time between sessions can improve treatment adherence and outcomes. Participants will undergo a five-day rTMS modulation followed by a four-week follow-up.
Who should consider this trial
Good fit: Ideal candidates are hospitalized or outpatient adults aged 18-65 who have treatment-resistant depression and have not responded to at least two antidepressants.
Not a fit: Patients with other mental disorders 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 and time-efficient treatment option for patients with treatment-resistant depression.
How similar studies have performed: While rTMS has been established as a treatment for depression, this specific approach with a short inter-session interval is novel and has not been extensively tested in prior studies.
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 the depression disorder without psychotic symptoms, and currently experiencing the first episode or recurrence episode. * Total HAMD17 score ≥18 before randomization. * Total MADRS score ≥20 before randomization. * A stable or no-drug use for at least 4 weeks before randomization. The type and dose of the antidepressant regimen remained unchanged throughout the study. * No response (symptom improvement≥50%) in previous treatments with at least two antidepressants for a full dose and full course. * 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 (e.g., schizophrenia spectrum disorders, bipolar and related disorders, anxiety disorders, compulsion, and related disorders, trauma and stress-related disorders, etc.), or secondary depression; * 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. * 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.