Comparing two methods of rTMS therapy for major depression

Personalized Brain Functional Sector-guided rTMS Therapy Targeting DLPFC VS "5-centimeter Rule" for Major Depression

This study is testing if a new way of using brain stimulation therapy can help people with major depression feel better compared to the traditional method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 4 sites (Baoding, Hebei and 3 other locations)
• Trial ID: NCT05964023 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of pBFS-guided rTMS therapy targeting the dorsolateral prefrontal cortex (DLPFC) compared to the traditional '5 cm rule' method in treating patients with major depressive disorder (MDD). Eligible participants will be randomly assigned to one of the two treatment groups and will undergo a 21-day rTMS modulation, followed by follow-up visits at 7, 14, and 45 days post-treatment. The study aims to determine if the pBFS approach provides superior therapeutic effects over the conventional method. All participants will refrain from other antidepressant treatments during the study period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with recurrent major depressive disorder who have not responded adequately to previous antidepressant treatments.

Not a fit: Patients with other mental disorders or those currently taking antidepressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective rTMS treatment protocols for patients suffering from major depression.

How similar studies have performed: Previous studies have shown varying success with rTMS therapies, but this specific comparison of pBFS versus the 5-cm rule is novel.

Eligibility criteria

Inclusion Criteria:

* 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 recurrence episodes.
* Inpatients or outpatients aged 18-65 years (inclusive), male or female.
* Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before randomization.
* Inadequate response to at least one antidepressant trial of adequate doses and duration.
* Currently not taking any antidepressant medication. If previously medicated, a washout period of 7 days is required.
* 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;
* The female of childbearing potential plans to become pregnant during the trial and the 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 3 other locations

• Hebei Mental Health Center — Baoding, Hebei, China (Recruiting)
• Henan Mental Hospital — Xinxiang, Henan, China (Recruiting)
• Tianjin general hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Hangzhou Seventh People's Hospital — Hanzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Meiling Li, Ph.D.

Conditions Major Depression; MDD; Major Depression, MDD; pBFS,; 5cm rule