Major Depressive Disorder (MDD)NCT07479758
Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
An observational study of Major Depressive Disorder (MDD) and Schizophrenia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Schizophrenia, Bipolar Disorder
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Jun 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang
Hangzhou, Zhejiang, 310000
Zheng Lin, 86-13757118261, Linzzr@126.com
About this study
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.
- 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.
Read more
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.
- Keywords
- Ultra-High-Field MRI, Visual Perception, Magnetic Resonance Spectroscopy, Mental Health Biomarkers
- Medical subject headings
- Depressive Disorder, Major, Schizophrenia, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline and 4 weeks post-treatment
Secondary outcomes (5)
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).
Measured: Baseline and 4 weeks post-treatment
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).
Measured: Baseline and 4 weeks post-treatment
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).
Measured: Baseline and 4 weeks post-treatment
Visual motion perception speed
Performance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values
Measured: Baseline and 4 weeks post-treatment
Binocular rivalry perceptual switching rate
Perceptual switching rate during binocular rivalry task assessed via psychophysical experiments.Unit of Measure: Number of switches per minute
Measured: Baseline and 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Nov 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479758
- Sponsor's protocol ID
- 2025-11-20
- Status last verified
- Nov 2025
- First submitted
- 4 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
- ClinicalTrials.gov ID
- NCT07479758
- Acronym / sponsor ID
- 2025-11-20
- Keywords
- Ultra-High-Field MRI, Visual Perception, Magnetic Resonance Spectroscopy, Mental Health Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
5 secondary outcomes
Severity of depressive symptoms in MDD patients
Time frame: Baseline and 4 weeks post-treatment
Severity of psychotic symptoms in SZ patients
Time frame: Baseline and 4 weeks post-treatment
Severity of manic symptoms in BD patients
Time frame: Baseline and 4 weeks post-treatment
Visual motion perception speed
Time frame: Baseline and 4 weeks post-treatment
Binocular rivalry perceptual switching rate
Time frame: Baseline and 4 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD) and Schizophrenia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Lin (86-13757118261, Linzzr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of gamma-aminobutyric acid (GABA) in visual cortex (time frame: Baseline and 4 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.