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| ID | Type | Description | Link |
|---|---|---|---|
| 2018ZX09734-005 | Other Grant/Funding Number | China National Major Project for IND |
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| Name | Class |
|---|---|
| Su Zhou YiHua Biotechnology Co. LTD | UNKNOWN |
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The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anyu Peibo | Experimental | Anyu Peibo Capsule, oral, 0.8g twice per day |
|
| Placebo | Placebo Comparator | Placebo,oral, twice per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anyu Peibo | Drug | Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change of total score from baseline in Montgomery Asberg Depression Rating Scale (MADRS) | the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission Rate according to total score of MADRS at the end of study | Remission=at the end of study, total score of MADRS ≤10, the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome | 8 weeks |
| Clinical Remission Rate according to 17-items Hamilton Depression Scale (HAMD17) total score at the end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huafang LI, MD. PhD. | Contact | 86-21-34773107 | lhlh_5@163.com | |
| Yiming YU, Master | Contact | 86-21-34773128 | mindyfish2001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD. PhD. | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100088 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34479619 | Derived | Huang J, Yu Y, Jiang Y, Chen W, Li Y, Shen Y, Zheng Q, Li H. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial. Trials. 2021 Sep 3;22(1):585. doi: 10.1186/s13063-021-05550-9. |
| Label | URL |
|---|---|
| EMEA :Guideline on clinical investigation of medicinal products in the treatment of depression. | View source |
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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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| Placebo |
| Drug |
Placebo Capsule, twice per day, oral after breakfast and supper |
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Remission=at the end of study, total score of HAMD17 ≤7, the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome |
| 8 weeks |
| The change of total score of MADRS by time | the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome | 8 weeks |
| The change of total score from baseline in HAMD17 | the minimum and maximum values of HAMD17 are from 0 to 52, and higher scores mean a worse outcome | 8 weeks |
| The change of total score from baseline in Hamilton Anxiety Scale (HAMA) | the minimum and maximum values of HAMA are from 0 to 56, and higher scores mean a worse outcome | 8 weeks |
| The change of score from baseline in Clinical Global Impression-Severity of Illness (CGI-S) | the minimum and maximum values of CGI-S are from 1 to 7, and higher scores mean a worse outcome | 8 weeks |
| Clinical Global Impression-Severity of Illness (CGI-I) score | the minimum and maximum values of CGI-I are from 1 to 7, and higher scores mean a worse outcome | 8 weeks |
| The change of total score from baseline in Discriminative Scale Space Tracker (DSST) | the minimum and maximum values of DSST are from 0 to 90, and higher scores mean a better outcome | 8 weeks |
| The change of total score from baseline in Trail Making Test (TMT) A&B | the minimum and maximum values of TMT are from 0 to 300, and higher scores mean a worse outcome | 8 weeks |
| The change of total score from baseline in Sheehan Disability Scale (SDS) | the minimum and maximum values of SDS are from 0 to 10, and higher scores mean a worse outcome | 8 weeks |
| Proportion of subjects who withdrew from clinical trial due to poor efficacy | Investigator will assess subject's efficacy according to his/her clinical status with rating scales, including MADRS, HAMD17, HAMA and CGI, which already listed in Outcome | 8 weeks |
| Proportion of subjects who combined medication to treat insomnia | 8 weeks |
| Incidence rate of AE | AE=Adverse Events | 8 weeks |
| Breath Rate | per minutes | 8 weeks |
| Pulse Rate | per minutes | 8 weeks |
| Heartbeat Rate | per minutes | 8 weeks |
| Diastolic blood pressure | Sitting position, mmHg | 8 weeks |
| Systolic blood pressure | Sitting position, mmHg | 8 weeks |
| Electrocardiogram(ECG) | the number of subjects with abnormal ECG report by 12-lead electrocardiogram | 8 weeks |
| Assessment of Arizona Sexual Experience Scale (ASES) | the minimum and maximum values of ASES are from 1 to 6, and higher scores mean a worse outcome | 8 weeks |
| Number of Participants with AE result in early withdrawal from clinical trials | 8 weeks |
| Number of Participants with Serious Adverse Event (SAE) result in early withdrawal from clinical trials | 8 weeks |
| Number of Emerging AE during drug withdrawal period | 9 weeks |
| Beijing HuiLongGuan Hospital | Recruiting | Beijing | Beijing Municipality | 100096 | China |
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| Peking University Sixth Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Chongqing Mental Health Center | Recruiting | Chongqing | Chongqing Municipality | 400036 | China |
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| Guangzhou Brain Hospital | Recruiting | Guangzhou | Guangdong | 510370 | China |
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| The Sixth People's Hospital of Hebei Province | Recruiting | Baoding | Hebei | 071000 | China |
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| The Second Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453002 | China |
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| Zhumadian mental Hospital | Recruiting | Zhumadian | Henan | 463000 | China |
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| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
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| Wuxi Mental Health Center | Recruiting | Wuxi | Jiangsu | 214063 | China |
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| Jiangxi Mental Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| Brain Hospital of Jilin Province | Recruiting | Siping | Jilin | 136000 | China |
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| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| XI'AN Mental Health Center | Recruiting | Xi’an | Shanxi | 710061 | China |
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| Ningbo Kangning Hospital | Recruiting | Ningbo | Zhejiang | 315201 | China |
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| FDA.Major Depressive Disorder:Developing Drug for Treatment Guidance for Industry. | View source |