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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432688
• Other study ID #: DSPCLAT-001
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: June 18, 2023

Study information

• Verified date: April 2024
• Source: Sumitomo Pharma (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

It's a prospective, non-interventional, observational Post-marketing Surveillance..

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 information / eligibility

• Status: Completed
• Enrollment: 3192
• Est. completion date: June 18, 2023
• Est. primary completion date: March 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone HCl
This is a non-interventional, observational study

Locations

Country	Name	City	State
China	Beijing Anding Hospital	Beijing	Beijing
China	Brain Hospital of Hunan Province	Changsha	Hunan
China	The first specialized hospital of Harbin	Harbin	Heilongjiang
China	Shandong Mental Health Center	Jinan	Shandong
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Anding Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Adverse Event	Adverse events	week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in body weight at the end of treatment compared with baseline	Weight is measured on a scale	baseline/ week 12
Secondary	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