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| ID | Type | Description | Link |
|---|---|---|---|
| 2012ZX09303-003 | Other Grant/Funding Number | China National Major Project |
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| Name | Class |
|---|---|
| Shanghai Innovative Research Center of Traditional Chinese Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yuxintine 200mg per day | Experimental | Yuxintine 200mg oral, once a day, 6 weeks |
|
| Yuxintine 300mg per day | Experimental | Yuxintine 300mg oral, once a day, 6 weeks |
|
| Yuxintine 400mg per day | Experimental | Yuxintine 400mg oral, once a day, 6 weeks |
|
| Placebo | Placebo Comparator | Placebo oral, once a day, 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yuxintine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of total score from baseline in MADRS scale | 6 weeks |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| vital sign | Blood pressure, heart rate, temperature and respiratory rate | 6 weeks |
| The Arizona Sexual Experience Scale (ASEX) | 6 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang LI, MD PhD | Contact | 86-21-34773128 | lhlh_5@163.com | |
| Yifeng SHEN, MD PhD | Contact | 86-21-34773215 | shenyifeng@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100083 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| 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 |
| laboratory examination |
Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,Thyroid Function, Blood Coagulation Test and U-HCG |
| 6 weeks |
| AE(adverse events) | 6 weeks |
| ECG | 6 weeks |
| Early Termination | 6 weeks |
| Beijing HuiLongGuan Hospital | Beijing | Beijing Municipality | 100096 | China |
|
| the First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 404000 | China |
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| Shenzhen Mental Health Center | Shenzhen | Guangdong | 518020 | China |
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| the People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
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| Affiliated Hospital of Guiyang Medical College | Guiyang | Guizhou | 550004 | China |
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| Hebei Mental Health Center | Shijiazhuang | Hebei | 071000 | China |
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| Hunan Brain Hospital | Changsha | Hunan | 410007 | China |
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| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300074 | China |
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