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.
Study Type
OBSERVATIONAL
Enrollment
3,192
This is a non-interventional, observational study
Beijing Anding Hospital
Beijing, Beijing Municipality, China
The first specialized hospital of Harbin
Harbin, Heilongjiang, China
Brain Hospital of Hunan Province
Changsha, Hunan, China
Shandong Mental Health Center
Jinan, Shandong, China
The incidence of Adverse Event
Adverse events
Time frame: week 12
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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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).
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
Time frame: baseline/ week 2-4/ week 6-8/ week 12