Validating and Optimizing Model of Antipsychotics Selection

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: model
* Other: non-model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An in-patient or out-patient (male or female) and aged ≥18 years A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine-5) Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures. Patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole. Baseline PANSS Total Score ≥70 Exclusion Criteria: Participation in other clinical studies. Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole. Use of clozapine within 28 days prior to randomization. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: model<br>model aided decision | Other: model<br>* a model that has been established in advance.<br>* Other names: model aided decision;|
| Active Comparator: non-model<br>real-world psychiatrist decision | Other: non-model<br>* real-world psychiatrist decision<br>* Other names: non-model decision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of PSP from Baseline | PSP assessment at 52 weeks | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |