RecruitingNCT07479758

Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

320 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study aiming to screen biomarkers associated with the diagnosis and treatment outcomes of severe mental disorders (MDD/major depressive disorder, SZ/schizophrenia, BD/bipolar disorder) through 7T ultra-high-field magnetic resonance multimodal imaging and visual perception assessment, thereby optimizing the objectivity and precision of clinical diagnosis and treatment. I. Core Research Objectives 1. Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment. 2. Establish a biomarker system related to disease diagnosis and treatment outcomes to make up for the limitation of current clinical reliance on phenomenological diagnosis. II. Study Subjects and Inclusion/Exclusion Criteria 1. Recruitment Scope * Patient group: MDD, SZ, and BD patients diagnosed in the Department of Psychiatry, the Second Affiliated Hospital of Zhejiang University School of Medicine. * Healthy control group: Healthy individuals without a history of mental illness recruited from the general population. 2. Key Criteria * Inclusion: Aged 18-45 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria (for the patient group); no organic brain injury or severe physical illness; signing the informed consent form. * Exclusion: Organic brain diseases; severe physical illnesses (e.g., tumors); internal metal implants (e.g., cardiac pacemakers); claustrophobia or inability to tolerate MR examinations; pregnancy, etc. III. Core Study Procedures 1. All participants will undergo 2 sessions of 7T MRI scans (including MRS, fMRI, and other multimodal sequences), focusing on the MT+ brain region and V1 brain region respectively, with the scan order randomly balanced. 2. During the interval between the two MRI scans, participants will complete visual psychophysical experiments, cognitive function tests (e.g., BDT test), and clinical symptom collection. 3. The study will not interfere with routine clinical treatment and strictly adheres to the ethical standards of the Second Affiliated Hospital of Zhejiang University School of Medicine (Ethical Approval No.: 2025 Lun Shen Yan Di 0603). IV. Study Significance 1. Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders. 2. Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is using ultra-high-field MRI brain scans and visual perception tests as research tools to better understand and diagnose severe mental health conditions — including depression, schizophrenia, and bipolar disorder. Researchers are looking for brain-based markers that could help detect these conditions earlier or monitor treatment. **You may be eligible if...** - You are between 18 and 45 years old - You have been diagnosed with major depressive disorder, schizophrenia, or bipolar disorder (based on standard diagnostic criteria), OR - You are a healthy volunteer with no mental health history (to serve as a comparison group) - You have no serious physical illnesses or history of brain injury - You are able to provide consent (or your guardian can) **You may NOT be eligible if...** - You have had a significant head injury or brain disease like epilepsy - You have a serious physical illness such as cancer or thyroid disease - You have metal implants in your body (e.g., a pacemaker or brain device) that are unsafe for MRI - You are claustrophobic or cannot tolerate an MRI machine - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang

Hangzhou, Zhejiang, China

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NCT07479758


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