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Differential diagnosis of unipolar depression and bipolar depression based on neurogenic exosome miRNA

Differential diagnosis of unipolar depression and bipolar depression based on neurogenic exosome miRNA

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048661
Enrollment
Unknown
Registered
2021-07-12
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-21

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:Hamilton Depression Scale 17 items, Young's Manic Scale, DSM-5, M.I.N.I scale.
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were&#32
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and&#32
sequenced
Biomarker:&#32
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MiSeq.

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for uniphasic depression : 1.Subjects voluntarily signed informed consent; 2.Aged 18 to 60 years, regardless of gender; 3.Meets the diagnostic criteria for a DSM-5 major depressive episode; 4.Patients with recurrent clinical depression, the number of previous depressive episodes >=2; 5.The total score of 17 items on the Milton Depression Scale (HAMD17) is >=17 points; 6.Sufficient audio-visual proficiency to carry out the necessary examinations for the study; 7.No drug use within 3 months prior to recruitment (generally 3-5 drug half-life). Inclusion criteria for bipolar depressive episode: 1.Subjects voluntarily signed informed consent; 2.Aged 18 to 60 years, regardless of gender; 3.Meets the diagnostic criteria for DSM-5 bipolar disorder BD-II; 4.A current or recent episode of depression; 5.The total score of 17 items in the Hamilton Depression Scale (HAMD17) was >=17, and the total score of Young's Mania Scale (YRMS) was <6; 6.No drug use within 3 months prior to recruitment (generally 3-5 drug half-life); 7.Sufficient audio-visual proficiency to carry out the necessary examinations for the study. Inclusion criteria for healthy subjects were : 1.The M.I.N.I scale and the assessment at admission did not meet any of the DSM-5 diagnostic criteria; 2.A total score of 17 items on the Hamilton Depression Scale (HAMD17) <=7; 3.No history of major medical or mental illness; No family history of mental illness. 4.Sufficient audio-visual proficiency to carry out the necessary examinations for the study; 5.Subjects voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Schizophrenia or schizoaffective disorder meeting DSM-5 diagnostic criteria; 2.Patients with serious surgical or physical diseases (such as cancer, kidney dialysis, etc.), organic brain diseases, neurological diseases or mental retardation; 3.Abuse or dependence of comorbidities; 4.Pregnant or lactating women; 5.Uncooperative or difficult to complete the scale evaluation; 6.Severe suicide attempt (HAMD-17, item 3, "suicide" score >=3); 7.Patients who had received electroconvulsive therapy in the past month.

Design outcomes

Primary

MeasureTime frame
17 items on the Milton Depression Scale;Young Mania Rating Scale;Concise International Neuropsychiatric Interview Scale;Diagnostic and Statistical Manual of Mental Disorders (Fifth edition) scale;

Countries

China

Contacts

Public ContactZhang Chen
zhangchen645@gmail.com+86 17701754504

Outcome results

None listed

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