pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression

Launched by CHANGPING LABORATORY · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called repetitive Transcranial Magnetic Stimulation (rTMS) for people who suffer from treatment-resistant depression, which means their depression hasn’t improved with standard medications. The study is being conducted in multiple locations and aims to see if this rTMS method, targeted specifically at a brain area known as the Dorsomedial Prefrontal Cortex (DMPFC), is effective and safe for patients. To be eligible to participate, individuals must be between 18 and 65 years old, have a significant level of depression symptoms, and have been on at least one antidepressant for at least six weeks without improvement.

Participants in the trial can expect to receive either the active rTMS treatment or a placebo (a treatment that looks the same but has no active effect) in a double-blind setup, meaning neither the participants nor the researchers will know who receives which treatment during the study. It's important to note that certain people, such as those with specific other mental health conditions or serious physical health issues, will not be eligible to participate. The goal is to find better ways to help those who have not found relief from their depression through traditional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and are not accompanied by psychiatric symptoms, with single or repeated episodes;
• • (2) The Hamilton Depression Scale (HAMD) score for 17 items before randomization was ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score was ≥ 20 points;
• • (3) Individuals aged ≥ 18 and ≤ 65 years old, regardless of gender;
• • (4) Currently, at least one antidepressant has been used for 6 weeks and the dosage used cannot be lower than the prescribed range of drug use;
• • (5) The Maudsley Staging Method (MSM) assesses patients as having at least moderate refractory levels (MSM score ≥ 7);
• • (6) Before randomization, the current antidepressant treatment regimen should be stable for at least 4 weeks, and the dosage used should not be lower than the prescribed range of drug use;
• • (7) Having received education for 5 years or more;
• • (8) Understand the experiment and sign an informed consent form.
• Exclusion Criteria:
• • (1) Meets the DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or depression caused by other medical issues;
• • (2) Individuals with pacemakers, cochlear implants, or other metal foreign objects, as well as any electronic devices implanted in the body, contraindications for magnetic resonance imaging scans such as claustrophobia, and contraindications for rTMS treatment;
• • (3) Concomitant history of epilepsy (with at least 2 non induced seizures with an interval of more than 24 hours, diagnosed with epilepsy syndrome, or having seizures within the past 12 months);
• • (4) Individuals who have received modified electroconvulsive mECT, rTMS, or light therapy within 3 months;
• • (5) Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
• • (6) Complicated with serious heart, liver, kidney diseases, diabetes and other serious physical diseases;
• • (7) Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
• • (8) Have a history of drug and alcohol abuse within the past year;
• • (9) First degree relatives suffer from bipolar disorder;
• • (10) There is a significant risk of suicide (the 10th item of the MADRS scale is ≥ 5 points);
• • (11) Difficulty in verbal communication to the point of being unable to communicate normally, understand or follow instructions, and unable to cooperate with treatment and evaluation;
• • (12) Currently participating in clinical trials of other drugs or physical therapies (such as deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS);
• • (13) The researchers believe it is not suitable to participate.