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This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance.
The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| model | Experimental | model aided decision |
|
| non-model | Active Comparator | real-world psychiatrist decision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| model | Other | a model that has been established in advance. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of PSP from Baseline | PSP assessment at 52 weeks | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of PANSS from Baseline | PANSS assessment at 52 weeks | 52 weeks |
| Change of CDSS from Baseline | CDSS assessment at 52 weeks | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifeng SHEN, MD PhD | Contact | 86-21-34773657 | shenyifeng@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifeng SHEN, MD PhD | GCP Office | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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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 |
|---|---|
| D008954 | Models, Biological |
| D017711 | Nonlinear Dynamics |
| ID | Term |
|---|---|
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
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| non-model | Other | real-world psychiatrist decision |
|
|
| Change of CGI from Baseline | CGI assessment at 52 weeks | 52 weeks |
| Change of liver function from Baseline | Liver function assessment at 52 weeks | 52 weeks |
| Change of PRL from Baseline | PRL assessment at 52 weeks | 52 weeks |
| Number of Participants with EPS | EPS assessment at 52 weeks | 52 weeks |
| Number of Participants with abnormal ECG | ECG assessment at 52 weeks | 52 weeks |
| Number of Participants with abnormal sexual function | sexual function assessment at 52 weeks | 52 weeks |