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A Study Using 40Hz ASSR Combined with fMRI, Cortical E/I Imbalance, and Machine Learning to Distinguish Between Major Depressive Disorder and Bipolar Disorder

A Study Using 40Hz ASSR Combined with fMRI, Cortical E/I Imbalance, and Machine Learning to Distinguish Between Major Depressive Disorder and Bipolar Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123922
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder, bipolar disorder

Interventions

Gold Standard:There is currently no definitive gold standard for this condition
it is generally diagnosed through scoring on questionnaires and interviews.(Montgomery-Åsberg Depression Rating Scale,Beck Depression Inventory,Young Mania Rating Scale)
Index test:Electroencephalogram (EEG) and fMRI

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Gender: Open to all; Age: 15–18 years old; 2.Right-handed; hearing screening results are normal; 3.Elementary school education or higher; 4.Preliminary cognitive assessment results are normal, and the subject is able to cooperate with scale evaluations, EEG recording, and fMRI scans; 5.The patient (aged 18 or older) or the patient’s legal guardian (if under 18) fully understands the study protocol and voluntarily signs the informed consent form. 6.Meets the diagnostic criteria for depressive disorders according to ICD-10, as confirmed by a psychiatrist using the M.I.N.I. interview; 7.MADRS score >= 12, BDI score >= 14; 8.Number of positive items on the Mood Disorders Questionnaire (MDQ) = 12, BDI score >= 14; Manic episode: YMRS score >= 13; 12.Health Group: Does not meet the diagnostic criteria for any mental disorder listed in ICD-10, as confirmed by a psychiatrist;

Exclusion criteria

Exclusion criteria: 1.Severe abnormalities in physical examination findings, laboratory biochemical test results, or EEG or ECG results; 2.Women who are pregnant or breastfeeding; 3.A history of alcohol, drug, or psychiatric medication dependence; 4.Individuals who cannot discontinue their current medication due to other medical conditions; 5.Have undergone electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within the past 6 months; 6.Depressive or manic episodes accompanied by psychotic symptoms (delusions, hallucinations, etc.); 7.A history of head trauma resulting in loss of consciousness lasting more than 1 hour; 8.Significant intellectual disability (e.g., IQ < 70); 9.Combined with other mental disorders (such as schizophrenia, obsessive-compulsive disorder, post-traumatic stress disorder, etc.), or mental disorders caused by organic brain disorders or physical illnesses; 10.Unable to cooperate with EEG recording or fMRI scanning (e.g., due to claustrophobia or metal implants);

Design outcomes

Primary

MeasureTime frame
Discrimination performance metrics;Functional connectivity strength of thalamocortical circuits;Source localization analysis results;ERSP/ITC: Event-related spectral perturbations, inter-trial phase coherence; Phase Locking Value (PLV): Early and late phases in the prefrontal (F3/F4), temporal (T7/T8), and central (C3/C4) regions;Cortical fEI measures: Resting-state fEI (?/a power ratio), ERP-fEI (?/a power ratio at 100–600 ms post-stimulus);EEG microstate features;

Secondary

MeasureTime frame
Clinical scale scores: Montgomery-?sberg Depression Rating Scale, Beck Depression Inventory, Young Mania Rating Scale, Mood Disorder Questionnaire scores;Follow-up parameters: Clinical outcome (cured/improved/no change/worsened), change in diagnosis, and progression of symptoms;Correlation measures: Correlation coefficients between neurophysiological measures and clinical scale scores;

Countries

China

Contacts

Public ContactMengqian li

The first affiliated hostipal of nanchang university

limengqian@126.com+86 791 88692280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026