Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), Schizophrenia, Bipolar Disorder, Severe Mental Disorders. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Concentration of gamma-aminobutyric acid (GABA) in visual cortex [Time frame: Baseline and 4 weeks post-treatment]
- Concentration of glutamate (Glu) in visual cortex [Time frame: Baseline and 4 weeks post-treatment]
Secondary outcome measures (5)
- Severity of depressive symptoms in MDD patients [Time frame: Baseline and 4 weeks post-treatment]
- Severity of psychotic symptoms in SZ patients [Time frame: Baseline and 4 weeks post-treatment]
- Severity of manic symptoms in BD patients [Time frame: Baseline and 4 weeks post-treatment]
- Visual motion perception speed [Time frame: Baseline and 4 weeks post-treatment]
- Binocular rivalry perceptual switching rate [Time frame: Baseline and 4 weeks post-treatment]
Eligibility criteria
Inclusion criteria
- Participants aged 18 to 45 years old at the time of enrollment
- Male or female participants
- For patients: A diagnosis of major depressive disorder (MDD), schizophrenia (SZ), or bipolar disorder (BD) based on DSM-5 criteria
- For healthy controls: No history of any mental health disorders
- No current severe medical illnesses or history of brain injury such as encephalitis
- Ability to provide written informed consent by the participant or their guardian
Exclusion criteria
- History of head injury or brain diseases such as epilepsy
- Presence of severe physical illnesses such as tumors or thyroid problems
- Presence of metal implants in the body like pacemakers or brain devices
- Fear of enclosed spaces (claustrophobia) or inability to undergo an MRI scan
- Current pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang — Hangzhou
Identifiers
NCT: NCT07479758 · 2025-11-20