Guided rTMS Therapy for Treatment-Resistant Depression

Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression

This study is testing if a new way of using brain stimulation can help adults with severe depression who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 1 site (Xinxiang, Henan)
• Trial ID: NCT05976022 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) targeting different areas of the prefrontal cortex in adults with moderate to severe treatment-resistant depression. By utilizing the pBFS method for precise targeting, the study aims to identify optimal stimulation sites that can activate distinct neural circuits associated with depressive symptoms. Participants will undergo rTMS interventions while their brain activity is monitored through individualized imaging analysis, which may enhance the personalization of treatment for major depressive disorder.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments.

Not a fit: Patients with psychotic symptoms or those who do not meet the criteria for treatment-resistant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatments for patients suffering from treatment-resistant depression.

How similar studies have performed: Previous studies have shown promise in targeting specific areas of the prefrontal cortex for rTMS, but this approach of individualized targeting using the pBFS method is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 ≥20 before randomization.
* Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
* 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.
* 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).
* 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;
* 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, and light therapy within 3 months;
* Patients with serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
* Patients 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;
* Female of childbearing potential who plans to become pregnant during the trial.
* Female that is pregnant or breastfeeding.
* Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
* 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.
* Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS).
* Investigators think that was inappropriate to participate.

Where this trial is running

Xinxiang, Henan

• Henan Mental Hospital — Xinxiang, Henan, China (Recruiting)

Study contacts

• Study coordinator: Meiling Li, Ph.D.

Conditions MDD; Major Depressive Disorder; Treatment Resistant Depression