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Clinical trials of ten depression-related metabolite determination kits (liquid chromatography-tandem mass spectrometry) combined with depression-assisted diagnostic software

Clinical trials of ten depression-related metabolite determination kits (liquid chromatography-tandem mass spectrometry) combined with depression-assisted diagnostic software

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112294
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Depression

Interventions

Gold Standard:The diagnostic criteria are based on the 10th edition of the International Classification of Diseases (ICD-10) and the Manual of Diagnostics and Statistics of Mental Disorders (DSM-5) a
Index test:The diagnostic test evaluated in this study is "Ten Types of Depression-Related Metabolite Determination Kits (Liquid Chromatography-Tandem Mass Spectrometry)" combined with "Depression Aux

Sponsors

CUHK Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate in the trial, and sign an informed consent form; 2. Subjects are aged >=18 and <= 60 years, with no gender restrictions; 3. Subjects meeting one of the following criteria: (1) Subjects diagnosed with depression according to the International Classification of Diseases, 10th Revision (ICD-10) criteria; (2) Non-depressed subjects who have been excluded from a diagnosis of depression based on ICD-10 diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1. Depression subjects have improved to the consolidation or maintenance period after treatment; 2.The subject was diagnosed with bipolar disorder or schizophrenia; 3.The subjects suffered from other mental diseases; 4.Oral or injecting hormone treatment in the last week; 5. People with a history of metabolic diseases such as diabetes, abnormal thyroidism, hyperuricemia, gout, etc. in the past year; 6. The patient has serious neurological diseases, brain trauma, cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases and other major somatic diseases; 7. Pregnant woman or breastfeeding; 8. Those who have undergone surgery within 3 months before screening (except outpatient surgery); 9. The researchers believe that there are samples of other factors that are not suitable to participate in this test.

Design outcomes

Primary

MeasureTime frame
Sensitivity;specificity;Positive/negative predictive value;

Countries

China

Contacts

Public ContactYuan Yonggui

CUHK Hospital Affiliated to Southeast University

yygylh2000@sina.com+86 139 1393 9082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026