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NCT Number: NCT07479758

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  1. 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).

  2. 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).

  3. 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).

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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