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Non-invasive BCI and Application Verification for Depressed People

RecruitingPhase 4Ages 12 Years - anyAllShanghai Mental Health Center
NCT06417437 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Major Depressive Disorder (MDD) is a serious mental illness and public health problem that poses threat to both physical and mental health. According to statistics from WHO, it is estimated that more than 350 million people worldwide suffer from depression, with a prevalence rate of 2.1% in China, which is approximately 30 million people. At present, due to the lack of neurobiological markers for screening and diagnosing depression, the identification and diagnosis of MDD are based on the judgment of professional doctors, and the treatment mostly relies on clinical symptoms. In terms of treatment, medication remains the main stream for MDD. Although current methods have certain therapeutic effects, patients still suffer from various side effects and poor cognitive function.In current clinical practice, relying purely on symptomatic diagnosis and treatment is difficult to meet the needs

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥ 12 years old, male or female, right-handed, Han ethnicity * Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6; * Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form Exclusion Criteria: * Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy; * Severe abnormalities in heart, liver, and kidney function; * Patients with severe physical illnesses; * History of substance dependence or abuse (alcohol, cocaine, drugs, etc.); * Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders; * Pregnancy or lactation period; * Within six months, physical therapy such as MECT and TMS should be used; * Implants of vegetative nerve stimulation; * Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery; * Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.
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What it tests

  • SSRI
  • rTMS
  • Neuro-Feedback
  • Game Regulation
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Where

1 site
Shanghai Mental Health Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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