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Screening for early diagnosis biomarkers of mental disorders in serum exosomes

Screening for early diagnosis biomarkers of mental disorders in serum exosomes

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026776
Enrollment
Unknown
Registered
2019-10-21
Start date
2019-10-17
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Mental disorders

Interventions

control group:N/A
bipolar affective disorder:N/A

Sponsors

The First Hospital of Shanxi Medical Unversity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Affective disorder 1. Be able to cooperate with all study procedures and sign informed consent to participate in the study voluntarily. 2. Have high compliance and were able to follow up on time. 3. Aged 18 to 55 years. 4. Meet the DSM-5 diagnostic criteria (using the concise international neuropsychiatric interview MINI) for depressive episodes and bipolar disorder (or who meet the ICD-10 diagnostic criteria for moderate and major depressive episodes/bipolar disorder diagnostic criteria) and can cooperate with treatment. 5. Never use drugs regularly. First episode schizophrenia 1. Be able to cooperate with all study procedures and sign informed consent to participate in the study voluntarily. 2. Have high compliance and were able to follow up on time. 3. Aged 18 to 55 years. 4. Meet the DSM-5 diagnostic criteria (using the concise international neuropsychiatric interview MINI) for schizophrenia (or who meet the ICD-10 diagnostic criteria for schizophrenia) and can cooperate with treatment. 5. Positive and negative symptom scale (PANSS) score at >= 60 points at screening visit and baseline visit. 6. Never use drugs regularly. 7. If a drug is being used but the clinician thinks a change is needed (poor efficacy or intolerance).

Exclusion criteria

Exclusion criteria: Affective disorder 1. Psychiatric history Do not exclude other organic or medically induced secondary depressive disorder, or bipolar disorder. Have severe suicidal or impulsive tendencies at present. Have a history of other serious mental disorders. Have evidence of alcohol or other substance dependence or abuse. 2. Other medical history Have serious physical diseases and organic brain diseases. Have a serious disease of the body or nervous system revealed by laboratory or physical examination that had not been eliminated. 3. Medical history Take drugs that have central nervous system effects or that may affect mood with long-term. 4. Childbearing history Woman who is pregnant or lactating. 5.Others Have a contraindication to MRI. Participated in other clinical trials within 30 days. First episode schizophrenia Do not exclude other organic or medically induced secondary depressive disorder, or bipolar disorder Have severe suicidal or impulsive tendencies at present. Have a history of other serious mental disorders. Have evidence of alcohol or other substance dependence or abuse. 2. Other medical history Have serious physical diseases and organic brain diseases. Have a serious disease of the body or nervous system revealed by laboratory or physical examination that had not been eliminated. 4. Childbearing history Woman who is pregnant or lactating. 5.Others Cannot take medication as prescribed or do not have guardians. Have a contraindication to MRI. Participated in other clinical trials within 30 days.

Design outcomes

Primary

MeasureTime frame
cognitive function;cognitive function;psychologic status;Head mri;electroencephalography;

Countries

China

Contacts

Public ContactXinrong Li

The First Hospital of Shanxi Medical Unversity

18635107987@163.com+86 18635107987

Outcome results

None listed

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