rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS

Launched by CHANGPING LABORATORY · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) to help adults with major depressive disorder who have not responded well to traditional antidepressant medications. The goal is to see how effective and safe rTMS can be when different parts of the brain are targeted, using a method called pBFS to identify the best areas for treatment. Researchers also want to understand how the brain responds to this therapy by looking at brain images from participants.

To be eligible for the trial, participants should be between 18 and 65 years old and diagnosed with major depression without psychotic symptoms, currently experiencing a relapse. They must have tried at least one antidepressant that didn’t work for them and have moderate to severe depression symptoms. Participants will receive rTMS treatment and will be closely monitored throughout the study. It's important to note that certain people, such as those with specific medical conditions or mental disorders, may not be able to participate. Overall, this trial aims to provide new insights into effective treatments for individuals struggling with treatment-resistant depression.

Gender

ALL

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.