The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
1 other identifier
observational
3,192
1 country
7
Brief Summary
It's a prospective, non-interventional, observational Post-marketing Surveillance..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2023
CompletedApril 18, 2024
April 1, 2024
2.3 years
June 9, 2020
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of Adverse Event
Adverse events
week 12
Secondary Outcomes (5)
The incidence of extrapyramidal symptom
baseline/ week 2-4/ week 6-8/ week 12
The incidence of akathisia
baseline/ week 2-4/ week 6-8/ week 12
the rate of use of extrapyramidal symptom treatment drugs
baseline/ week 2-4/ week 6-8/ week 12
Changes in body weight at the end of treatment compared with baseline
baseline/ week 12
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
Study Arms (1)
Latuda®
Chinese schizophrenia patients who are receiving Latuda® in the real world
Interventions
Eligibility Criteria
Schizophrenia Patients who begin to receive Latuda®
You may qualify if:
- Schizophrenia Patients who begin to receive Latuda®
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088, China
The first specialized hospital of Harbin
Harbin, Heilongjiang, 150056, China
Brain Hospital of Hunan Province
Changsha, Hunan, 410000, China
Shandong Mental Health Center
Jinan, Shandong, 250014, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300074, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yifeng Xu
Shanghai Mental Health Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 16, 2020
Study Start
December 1, 2020
Primary Completion
March 18, 2023
Study Completion
June 18, 2023
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share