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| Name | Class |
|---|---|
| Zhejiang Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
This study design is subject to relevant SFDA regulations about clinical trials. Patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). After screening and washout period, eligible patients will be randomly assigned to the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will be hospitalized for the entire duration of the study. Patients' condition will be assessed weekly.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole tablet, 5-30mg/day, oral, 6 weeks | Drug | |||
| Risperidone tablet, 1-6mg/day, oral, 6 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Deduction rate of PANSS total |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS positive | ||
| PANSS negative | ||
| CGI |
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Inclusion Criteria:
Inclusion criteria for screening
1.PANSS total of no less than 60 2.3-7days washout with placebo is required after discontinuation of other oral antipsychotics; No washout is needed for patients who had never taken any antipsychotics before; In cases that patients's condition is deemed clinically deteriorating and immediate treatment is needed, patients with less than 3 days' placebo washout could be randomized after notifying the sponsor 3.No serious function impairment in heart, liver or kidney.
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Exclusion Criteria:
For screening
1. Diagnosis of other mental diseases besides schizophrenia during the washout period 2. Significant abnormal ECG or laboratory examination results (ALT,AST>1.5 times of higher limit of normal range), not suitable to be enrolled based on the investigator's discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Liang Shu, Professor | Institute of Mental Health, Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Brain Hospital | Guangzhou | Guangdong | China | |||
| Psychiatry Dept. People's Hospital, Wuhan University |
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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 |
|---|---|
| D000068180 | Aripiprazole |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| CGI improvement |
| Wuhan |
| Hubei |
| China |
| Mental Health Hospital, Nanjing Medical University | Nanjing | Jiangsu | China |
| Anding Hosp. Capital University of Medical Science | Beijing | China |
| Institute of Mental Health, Peking University | Beijing | China |
| Shanghai Mental Health Center | Shanghai | China |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |