Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Concentration of gamma-aminobutyric acid (GABA) in visual cortex
Study Overview
Brief 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
- Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment.
- 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
- 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.
- 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
- 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.
- 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.
- 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
- Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders.
- Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Control (HC)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).
Major Depressive Disorder (MDD)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).
Schizophrenia (SZ)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for schizophrenia; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.
Bipolar Disorder (BD)
Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for bipolar disorder; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.
Outcomes
Primary Outcomes
Concentration of gamma-aminobutyric acid (GABA) in visual cortex
Time Frame: Baseline and 4 weeks post-treatment
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
Time Frame: Baseline and 4 weeks post-treatment
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(Baseline and 4 weeks post-treatment)
- Severity of psychotic symptoms in SZ patients(Baseline and 4 weeks post-treatment)
- Severity of manic symptoms in BD patients(Baseline and 4 weeks post-treatment)
- Visual motion perception speed(Baseline and 4 weeks post-treatment)
- Binocular rivalry perceptual switching rate(Baseline and 4 weeks post-treatment)
