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Clinical Study on Xinyue Prescription Improving Cognitive Impairment of Senile Depressio

Phase 1
Recruiting
Conditions
Improving Cognitive Impairment of Senile Depression
Registration Number
ITMCTR2100004459
Lead Sponsor
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. In line with the diagnostic criteria of depression and mild cognitive impairment in traditional Chinese medicine and western medicine, the score of Hamilton Depression Scale was 20-35, and the score of Montreal Cognitive Assessment Scale (Beijing version) was < 26. The TCM syndrome type was Yin deficiency and liver depression, and no intercommunication between heart and kidney.
2. Male and female patients aged 60-85 years.
3. Patients first depressive episode after age 60.
4. Primary school education or above.
5. Signed Informed Consent.
6. Good compliance.

Exclusion Criteria

1. Organic or drug caused by secondary depression disorder.
2. Depressive disorder secondary to schizophrenia and other psychiatric disorders.
3. Severe affective disorder, depressive episode of bipolar disorder, reactive depressive disorder and other disease states of depressive syndrome.
4. Patients who have taken sedative sleeping pills, other drugs that have effects on cognitive function or antidepressants within the last 2 weeks.
5. Dependence or abuse of alcohol or other substances.
6. Suicide score > 2 on HAMD scale.
7. Complicated with severe liver and kidney dysfunction, other serious primary diseases that affect life span, tumors, organic brain diseases, visual and hearing impairment, etc.
8. Previous dementia patients.
9. Cannot cooperate to complete the test.
10. Have a history of severe drug allergy.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
HAMD depression scale score;MoCA scale score;
Secondary Outcome Measures
NameTimeMethod
BDNF, IL-1ß, IL-6 and TNF-a;TCM syndrome scores;
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