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

April 26, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zheng Lin
Phone Number: 86-13757118261
Email: Linzzr@126.com

Study Locations

China
- Zhejiang
  - Hangzhou, Zhejiang, China, 310000
    - Recruiting
    - Second Affiliated Hospital, School of Medicine, Zhejiang
    - Contact:
      
      Zheng Lin
      
      Phone Number: 86-13757118261
      
      Email: Linzzr@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 4 weeks post-treatment
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)	Baseline and 4 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of depressive symptoms in MDD patients Time Frame: Baseline and 4 weeks post-treatment	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).	Baseline and 4 weeks post-treatment
Severity of psychotic symptoms in SZ patients Time Frame: Baseline and 4 weeks post-treatment	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).	Baseline and 4 weeks post-treatment
Severity of manic symptoms in BD patients Time Frame: Baseline and 4 weeks post-treatment	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).	Baseline and 4 weeks post-treatment
Visual motion perception speed Time Frame: Baseline and 4 weeks post-treatment	Performance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values	Baseline and 4 weeks post-treatment
Binocular rivalry perceptual switching rate Time Frame: Baseline and 4 weeks post-treatment	Perceptual switching rate during binocular rivalry task assessed via psychophysical experiments.Unit of Measure: Number of switches per minute	Baseline and 4 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified