The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
- Registration Number
- NCT04432688
- Lead Sponsor
- Sumitomo Pharma (Suzhou) Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3192
- Schizophrenia Patients who begin to receive Latuda®
Exclusion criteria:
- No exclusion criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Latuda® Lurasidone HCl Chinese schizophrenia patients who are receiving Latuda® in the real world
- Primary Outcome Measures
Name Time Method The incidence of Adverse Event week 12 Adverse events
- Secondary Outcome Measures
Name Time Method 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.
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).
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
Trial Locations
- Locations (7)
Brain Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
The first specialized hospital of Harbin
🇨🇳Harbin, Heilongjiang, China
Shandong Mental Health Center
🇨🇳Jinan, Shandong, China
Tianjin Anding Hospital
🇨🇳Tianjin, Tianjin, China
First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China