The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients

Study Overview
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Brief Summary
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It's a prospective, non-interventional, observational Post-marketing Surveillance..

Detailed Description
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It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of the surveillance is to observe the safety and overall effectiveness of Latuda® in the treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as well as the dose of Latuda® for monotherapy or combination therapy.

Official Title
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The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia Patients who begin to receive Latuda® Exclusion criteria: No exclusion criteria
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Latuda®<br>Chinese schizophrenia patients who are receiving Latuda® in the real world | Drug: Lurasidone HCl<br>* This is a non-interventional, observational study<br>* Other names: Latuda®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Adverse Event | Adverse events | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of extrapyramidal symptom | Extrapyramidal Symptoms (EPS) are drug-induced movement disorders that accur due to antipsychotic blockade of the nigrostriatal dopamine tracts, including acute dystonia, akathisia, antipsychotic-induced parkinsonism, tardive dyskinesia (TD) | baseline/ week 2-4/ week 6-8/ week 12 | 
| The incidence of akathisia | Akathisia is a side effect of antipsychotic drugs, presenting as restlessness, fidgeting of the legs, rocking, pacing, and the inability to sit or stand still. | baseline/ week 2-4/ week 6-8/ week 12 | 
| the rate of use of extrapyramidal symptom treatment drugs | extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects | baseline/ week 2-4/ week 6-8/ week 12 | 
| Changes in body weight at the end of treatment compared with baseline | Weight is measured on a scale | baseline/ week 12 | 
| The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline | Brief Psychiatric Rating Scale (BPRS) is a generic scale developed to measure clinical change in patients with schizophrenia and which can be used as a global measure of psychopathology. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = not present to 7 = extremely severe, with scores ranging from 18 to 126 (achieved through summing the item scores). | baseline/ week 2-4/ week 6-8/ week 12 |