Schizophrenia
Conditions
Brief summary
It's a prospective, non-interventional, observational Post-marketing Surveillance..
Detailed description
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.
Interventions
DRUGLurasidone HCl
This is a non-interventional, observational study
Sponsors
Sumitomo Pharma (Suzhou) Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Schizophrenia Patients who begin to receive Latuda®
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Adverse Event | week 12 | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of extrapyramidal symptom | baseline/ week 2-4/ week 6-8/ week 12 | 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) |
| The incidence of akathisia | baseline/ week 2-4/ week 6-8/ week 12 | 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. |
| the rate of use of extrapyramidal symptom treatment drugs | baseline/ week 2-4/ week 6-8/ week 12 | extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects |
| Changes in body weight at the end of treatment compared with baseline | baseline/ week 12 | Weight is measured on a scale |
| The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline | baseline/ week 2-4/ week 6-8/ week 12 | 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). |
Countries
China
Outcome results
None listed