Comparison of Yuxintine With Placebo in Treatment of MDD

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Yuxintine Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the Chinese Patients with Depression.

Official Title
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Proof Of Concept Study of Yuxintine in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial

Conditions
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Major Depressive Disorder (MDD)

Intervention / Treatment
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* Drug: Yuxintine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.2 and 296.3. The Subject with Heart-Spleen Deficiency based on the CTM. The total score of MADRS is ≥22 in both screening visit and baseline visit. The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 in both screening visit and baseline visit. The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent. Exclusion Criteria: The subject made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD. The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression. When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%. Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),or other medical disease. Had a history of seizure disorder,except infantile febrile convulsion. The subject has accepted psychosurgery or electroconvulsive therapy within 3 months. With psychotic symptoms. The subject has a history of mania episode, including manic, mixed or rapid cycle attack. The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition. The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond. Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function index above toplimit, abnormal coagulation function and clinical significance of abnormality, i.e. Prothrombin time shorten or extend more than 3 seconds or a dynamic variation or APTT prolonged more than 10 seconds,AND fibrinogen L or been progressive decline, or > 4.0 g/L). The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit. Known hypersensitivity to Ginseng, or at least to two kinds of drugs, or serious allergic physique. Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures. The subject could not take medication according to the doctor's advice. The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more than 2 weeks). The subject has participated in a drug clinical trial within 3 months before screening. The investigator think the subject is unsuitable to enrol in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yuxintine 200mg per day<br>Yuxintine 200mg oral, once a day, 6 weeks | Drug: Yuxintine<br> <br> |
| Experimental: Yuxintine 300mg per day<br>Yuxintine 300mg oral, once a day, 6 weeks | Drug: Yuxintine<br> <br> |
| Experimental: Yuxintine 400mg per day<br>Yuxintine 400mg oral, once a day, 6 weeks | Drug: Yuxintine<br> <br> |
| Placebo Comparator: Placebo<br>Placebo oral, once a day, 6 weeks | Drug: Yuxintine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of total score from baseline in MADRS scale |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response rate according to MADRS |  | 6 weeks | 
| clinical remission rate according to MADRS |  | 6 weeks | 
| CGI(CGI-S,CGI-I) |  | 6 weeks | 
| The change of total score from baseline in HAMD scale |  | 6 weeks | 
| decreasing rate from baseline in HAMD scale |  | 6 weeks | 
| clinical remission rate according to HAMD |  | 6 weeks | 
| change from baseline in HAMA |  | 6 weeks | 
| Traditional Chinese Medicine Syndrome Scale |  | 6 weeks |