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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Lurasidone HCl

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.

• Study Type: Observational
• Enrollment (Actual): 3192

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • Beijing Anding Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150056
      • The first specialized hospital of Harbin
  • Hunan
    • Changsha, Hunan, China, 410000
      • Brain Hospital of Hunan Province
  • Shandong
    • Jinan, Shandong, China, 250014
      • Shandong Mental Health Center
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • First Affiliated Hospital of Shanxi Medical University
  • Tianjin
    • Tianjin, Tianjin, China, 300074
      • Tianjin Anding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Schizophrenia Patients who begin to receive Latuda®

Description

Inclusion Criteria:

• Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Latuda®; Chinese schizophrenia patients who are receiving Latuda® in the real world	Drug: Lurasidone HCl; This is a non-interventional, observational study; Other Names: Latuda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of Adverse Event	Adverse events	week 12

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Yifeng Xu, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): March 18, 2023
• Study Completion (Actual): June 18, 2023

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: DSPCLAT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes