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CompletedNCT04432688Updated Apr 18, 2024

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

An observational study in Schizophrenia, sponsored by Sumitomo Pharma (Suzhou) Co., Ltd.. Completed at 7 sites in China. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Sumitomo Pharma (Suzhou) Co., Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,192
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Schizophrenia

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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 3,192 is above the median of 178 across 491 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Sumitomo Pharma (Suzhou) Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Schizophrenia Patients who begin to receive Latuda®

Inclusion criteria

  • Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria

Exclusion criteria:

  • No exclusion criteria
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,192 participants (actual)
Target follow-up
12 Weeks
Patient registry
Yes

Groups and cohorts

  • Latuda®

    Chinese schizophrenia patients who are receiving Latuda® in the real world

    Drug: Lurasidone HCl

Interventions

  • DrugLurasidone HCl

    This is a non-interventional, observational study

    Also known as: Latuda®

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What researchers measure

Primary outcomes

  1. The incidence of Adverse Event

    Adverse events

    Time frame: week 12

Secondary outcomes

  1. 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)

    Time frame: baseline/ week 2-4/ week 6-8/ week 12

  2. 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.

    Time frame: baseline/ week 2-4/ week 6-8/ week 12

  3. the rate of use of extrapyramidal symptom treatment drugs

    extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects

    Time frame: baseline/ week 2-4/ week 6-8/ week 12

  4. Changes in body weight at the end of treatment compared with baseline

    Weight is measured on a scale

    Time frame: baseline/ week 12

  5. 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).

    Time frame: baseline/ week 2-4/ week 6-8/ week 12

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Study locations

7 sites
  • Beijing Anding Hospital
    Beijing, Beijing 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 200030, China
  • First Affiliated Hospital of Shanxi Medical University
    Taiyuan, Shanxi 030001, China
  • Tianjin Anding Hospital
    Tianjin, Tianjin 300074, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04432688
Lead sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
Dec 1, 2020
Primary completion
Mar 18, 2023
Completion
Jun 18, 2023
Last update
Apr 18, 2024

Study contacts

Yifeng Xu
principal investigator · Shanghai Mental Health Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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