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| ID | Type | Description | Link |
|---|---|---|---|
| 2012ZX09303-003 | Other Grant/Funding Number | China National Major Project |
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| Name | Class |
|---|---|
| Su Zhou YiHua Biotechnology Co. LTD | UNKNOWN |
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The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anyu Peibo 0.4g per day | Experimental | Anyu Peibo Capsule, oral, 0.2g twice per day |
|
| Anyu Peibo 0.8g per day | Experimental | Anyu Peibo Capsule, oral, 0.4g twice per day |
|
| Anyu Peibo 1.2g per day | Experimental | Anyu Peibo Capsule, oral, 0.6g twice per day |
|
| Anyu Peibo 1.6g per day | Experimental | Anyu Peibo Capsule, oral, 0.8g twice per day |
|
| Placebo | Placebo Comparator | Placebo,oral, twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anyu Peibo | Drug | Placebo |
|
| 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 |
| AE(adverse events) | 6 weeks | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD PhD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui province hospital of TCM | Hefei | Anhui | 230031 | China | ||
| Guang'anmen Hospital |
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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 response rate according to HAMD | 6 weeks |
| clinical remission rate according to HAMD | 6 weeks |
| change from baseline in HAMA | 6 weeks |
| laboratory examination |
Blood RT, Urinalysis,Hepatic function,Renal function,FBG,Lipid,CK,HBV,Thyroid Function Test and U-HCG |
| 6 weeks |
| ECG | 6 weeks |
| C-SSRS | 6 weeks |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China |
| Guangzhou Huiai Hospital | Guangzhou | Guangdong | 510370 | China |
| Jiangsu province hospital of TCM | Nanjing | Jiangsu | 210029 | China |
| Wuxi Mental Health Center | Wuxi | Jiangsu | 214151 | China |