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Screening and validation of diagnostic biomarkers for patients with depression based on platelet exosome proteomics

Screening and validation of diagnostic biomarkers for patients with depression based on platelet exosome proteomics

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123359
Enrollment
Unknown
Registered
2026-04-25
Start date
2025-09-01
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

Depression (MDD) is a group of mental disorders with low mood, diminished interest and lack of willpower as the main symptoms. According to the World Health Organisation (WHO), about 350 million people worldwide are affected by depression, with a global prevalence rate of 4.4%, and depression has gradually become one of the major causes of disability worldwide.

Interventions

Drug-naive Group (Training set):None
Drug-treated Group (Training set):None
Healthy Control Group (Training set):None
Drug-naive Group (Validation set):None
Drug-treated Group (Validation set):None
Healthy Control Group (Validation set):None

Sponsors

Wuxi Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to or reach the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM-5 and The eleventh edition of the international Classification of Diseases (the eleventh revision) The first diagnostic criteria for depression in ICD-11 and not having received psychiatric drug treatment; 2. Chinese Han residents, aged between 18 and 65 years old; 3. Primary school education or above; 4. The score of the 17-item Hamilton Depression Scale (HAMD-17) is >=17 points; 5. Voluntarily participate in the research and sign the informed consent form. (1) Meeting or reaching the diagnostic criteria for depression as stipulated in DSM-5 and ICD-11, and having received antidepressant drug treatment for at least 2 weeks with stable condition; (2) Chinese Han residents, aged between 18 and 65 years old; (3) Primary school education or above; (4) HAMD-17 points >=17 points; (5) Voluntarily participate in the research and sign the informed consent form. 1) HAMD-17 score <=7 points, no personal or family history of mental illness, and no history of taking psychiatric drugs; 2) Chinese Han residents, aged between 18 and 65 years old; 3) Primary school education or above; 4) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Suffering from other mental disorders diagnosed by DSM-5 and ICD-11, such as schizophrenia, bipolar disorder, personality disorder, etc. 2. Patients with any previous history of modified electroconvulsive therapy (MECT). 3. Combined with serious physical diseases, such as coronary heart disease, thyroid dysfunction, etc. 4. There has been a history of craniocerebral trauma or epilepsy that led to loss of consciousness; 5. Has a history of drug or substance abuse/dependence; 6. Women who are pregnant, lactating or in the stage of preparing for pregnancy (childbearing); 7. Recently, there have been conditions such as fever, acute infection or infectious diseases.

Design outcomes

Primary

MeasureTime frame
Differential platelet-derived exosome protein expression profile;Candidate biomarkers;Diagnostic model performance metrics (AUC, sensitivity, specificity);Hamilton Depression Rating Scale-17 (HAMD-17) score;Montgomery-?sberg Depression Rating Scale (MADRS) score;Exosome characteristic markers (CD9, CD63, CD81);Exosome size distribution;Exosome morphology;

Secondary

MeasureTime frame
General demographic data (age, sex, BMI, education level, etc.);

Countries

China

Contacts

Public ContactYang Zimeng

Wuxi Mental Health Center

6242828011@stu.jiangnan.edu.cn+86 10 2120025

Outcome results

None listed

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