About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patient Group: Recruited from the Department of Psychiatry at The Second Affiliated Hospital of Zhejiang University School of Medicine, consisting of three subgroups: patients with major depressive disorder (MDD), schizophrenia (SZ), and bipolar disorder (BD), all meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria. Healthy Control (HC) Group: Recruited from the general public, with no history of mental disorder diagnosis. All participants are aged 18 to 45 years (inclusive), meet the study's inclusion/exclusion criteria (no severe physical illnesses, no organic brain injury, etc.), and will complete non-invasive assessments (7T MRI scans, visual psychophysical experiments, cognitive tests, and clinical symptom evaluations) as required. The patient group receives standard clinical treatment (no study-induced intervention) during the study period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Concentration of gamma-aminobutyric acid (GABA) in visual cortex
Concentration of GABA in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)
Concentration of glutamate (Glu) in visual cortex
Concentration of Glu in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)
Secondary outcomes
Severity of depressive symptoms in MDD patients
Clinical symptom severity as measured by the Hamilton Depression Rating Scale (HAMD).Unit of Measure: Total score on HAMD scale (Range 0-52, higher scores indicate greater severity).
Severity of psychotic symptoms in SZ patients
Clinical symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Unit of Measure: Total score on PANSS scale (Range 30-210, higher scores indicate greater severity).
Severity of manic symptoms in BD patients
Clinical symptom severity as measured by the Young Mania Rating Scale (YMRS).Unit of Measure: Total score on YMRS scale (Range 0-60, higher scores indicate greater severity).
Visual motion perception speed
Performance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values
Sponsors and contacts
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