A multicenter randomized, double-blind, controlled trial for efficacy of YueJu Pills in the treatment of antidepressant

Not Applicable

• Conditions: Depression

• Registration Number: ITMCTR1900002557
• Lead Sponsor: Zhongda Hospital affiliated to Southeast University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for DSM-V or ICD-10 depression;
2. Aged 18-65 years old;
3. Patients with mild to moderate depression, Hamilton Depression Scale (24 items) score 35 points = HAMD-24 = 20 points;
4. In the past 1 week, there have been no Chinese medicines used to treat depression (including Chinese medicine and decoction), western medicine (fluoxetine, escitalopram, venlafaxine, etc.), or in the short term (3-5) Those who have taken the above drugs within days) have been discontinued for more than 7 days;
5. Willing to accept 42 days of treatment, the subject informed consent, and signed informed consent;
6. Both are right-handed and emmetropia.

Exclusion Criteria

1. Patients with suicidal depression, the score of the third item of Hamilton Depression Scale = 2 points;
2. People who are suffering from mental illness other than depression, as well as those caused by external environmental disturbances or traumatic brain injury;
3. Pregnant or lactating women;
4. A history of drug allergy;
5. Under 18 years of age or 65 years of age or older;
6. Combined with severe primary diseases such as cardiovascular, pulmonary, liver and kidney and hematopoietic system, and patients with severe brain organic diseases and mental illness;
7. Alcohol and/or psychoactive substances, drug abusers and dependents (including sleeping pills);
8. Does not meet the inclusion criteria, does not use the drug according to the regulations, can not judge the efficacy or incomplete data, affecting the efficacy and safety judgment;
9. Unable to understand scale content due to lack of consciousness, language barriers, and intellectual and cultural level;
10. Left hand;
11. During the elution period (within 7 days), the patient's depressive symptoms return to a healthy state, that is, the Hamilton Depression Scale score = 20 points after the end of the elution period;
12. Those who have been depression for more than 2 years.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM constitutional judgment classification scale;HAMA;coated tongue;HAMD-24;MRI;

Secondary Outcome Measures

Name	Time	Method
MADRS;QIDS-SR16;PHQ-9;