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Completed

NCT Number: NCT04432688

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..

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anding Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Lurasidone HCl

Drug

This is a non-interventional, observational study

Other names: Latuda®

Primary outcomes

  1. The incidence of Adverse Event

    Time frame: week 12

    Adverse events

Secondary outcomes

  1. The incidence of extrapyramidal symptom

    Time frame: 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)

  2. The incidence of akathisia

    Time frame: 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.

  3. the rate of use of extrapyramidal symptom treatment drugs

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

    extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects

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

    Time frame: baseline/ week 12

    Weight is measured on a scale

  5. The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2020
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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