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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1131-0692 | Other Identifier | UTN |
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Primary Objective:
To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia
Secondary Objective:
To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.
The study duration by subject will include a 8-week treatment period with 3 follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amisulpride | Experimental | Patients are treated with Amisulpride referring to the dosage and usage section in Chinese Solian® PI. Amisulpride dosage is adjusted based on individual response and reaches the sufficiency within 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMISULPRIDE | Drug | Pharmaceutical form: tablet Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective percentage (PANSS score reduced rate≥50%) | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Early response rate (PANSS score reduced rate: at least 20%) | week 2 | |
| Positive and Negative Syndrome Scale (PANSS)-total score improvement | Baseline, Week 8 | |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28721051 | Derived | Liang Y, Yu X. Effectiveness of amisulpride in Chinese patients with predominantly negative symptoms of schizophrenia: a subanalysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1703-1712. doi: 10.2147/NDT.S140905. eCollection 2017. | |
| 28461752 | Derived | Liang Y, Yu X. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Clinical Global Impression Scale- Improvement (CGI-I) |
| Baseline, Week 8 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |