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

NCT07479758 | Recruiting

• 1 other identifier: 2025-11-20
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

• 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).
• 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.

Conditions

Schizophrenia; Major Depressive Disorder (MDD); Bipolar Disorder; Severe Mental Disorders

Keywords

Ultra-High-Field MRI; Visual Perception; Magnetic Resonance Spectroscopy; Mental Health Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline and 4 weeks post-treatment

• 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)

  Baseline and 4 weeks post-treatment

Secondary Outcomes (5)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Schizophrenia; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders

Central Study Contacts

Zheng Lin

CONTACT

86-13757118261; Linzzr@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 18, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-11

Locations

CN (1)