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It's a prospective, non-interventional, observational Post-marketing Surveillance..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latuda® | Chinese schizophrenia patients who are receiving Latuda® in the real world |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone HCl | Drug | This is a non-interventional, observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Adverse Event | Adverse events | week 12 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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Schizophrenia Patients who begin to receive Latuda®
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| Name | Affiliation | Role |
|---|---|---|
| Yifeng Xu | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital | Beijing | Beijing Municipality | 100088 | China | ||
| The first specialized hospital of Harbin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41847604 | Derived | Wei YM, Yang XD, Wang CS, Wang LL, Deng HL, Sang H, Xue AL, Zhu DM, Li YM, Liu XJ, Li HY, Shen YF; post-market surveillance investigators. Lurasidone in Schizophrenia Management: A Comprehensive 12-Week Post-Marketing Surveillance Study in Chinese Patients. Neuropsychiatr Dis Treat. 2026 Mar 12;22:588526. doi: 10.2147/NDT.S588526. eCollection 2026. |
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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 |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 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 |
| Harbin |
| Heilongjiang |
| 150056 |
| China |
| Brain Hospital of Hunan Province | Changsha | Hunan | 410000 | China |
| Shandong Mental Health Center | Jinan | Shandong | 250014 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Tianjin Anding Hospital | Tianjin | Tianjin Municipality | 300074 | China |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |