SchizophreniaNCT04432688
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
An observational study of Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 7 sites in China.
Trial summary
It's a prospective, non-interventional, observational Post-marketing Surveillance.. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone HCl
- How many people
- 3,192 participants
- Where
- 7 sitesChina
- Study dates
- 1 Dec 2020to 18 Jun 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Schizophrenia Patients who begin to receive Latuda®
Who may be able to join
- Schizophrenia Patients who begin to receive Latuda®
Who cannot join
- No exclusion criteria
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Anding Hospital
Beijing, Beijing Municipality, 100088
Brain Hospital of Hunan Province
Changsha, Hunan, 410000
The first specialized hospital of Harbin
Harbin, Heilongjiang, 150056
Shandong Mental Health Center
Jinan, Shandong, 250014
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300074
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone HCl
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HClDrug
Also called Latuda®
This is a non-interventional, observational study
| Study group | Role | What they receive |
|---|---|---|
| Latuda® | Chinese schizophrenia patients who are receiving Latuda® in the real world Receives: Drug: Lurasidone HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Adverse Event
Adverse events
Measured: week 12
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: baseline/ week 2-4/ week 6-8/ week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Dec 2020
- Primary completion18 Mar 2023
- Study completion18 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,192 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifeng Xu, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432688
- Sponsor's protocol ID
- DSPCLAT-001
- Status last verified
- Apr 2024
- First submitted
- 9 Jun 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei YM, Yang XD, Wang CS, Wang LL, Deng HL, Sang H, Xue AL, Zhu DM, Li YM, Liu XJ, Li HY, Shen YF; post-market surveillance investigators. Lurasidone in Schizophrenia Management: A Comprehensive 12-Week Post-Marketing Surveillance Study in Chinese Patients. Neuropsychiatr Dis Treat. 2026 Mar 12;22:588526. doi: 10.2147/NDT.S588526. eCollection 2026.
PubMed 41847604
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT04432688
- Acronym / sponsor ID
- DSPCLAT-001
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,192 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It's a prospective, non-interventional, observational Post-marketing Surveillance..
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latuda® | – | Drug: Lurasidone HClChinese schizophrenia patients who are receiving Latuda® in the real world |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Schizophrenia Patients who begin to receive Latuda®
Key inclusion criteria (1 listed)
- Schizophrenia Patients who begin to receive Latuda®
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lurasidone HClAlso: Latuda®This is a non-interventional, observational study | Drug | Latuda® |
Primary outcome
The incidence of Adverse Event
Time frame: week 12
Adverse events
5 secondary outcomes
The incidence of extrapyramidal symptom
Time frame: baseline/ week 2-4/ week 6-8/ week 12
The incidence of akathisia
Time frame: baseline/ week 2-4/ week 6-8/ week 12
the rate of use of extrapyramidal symptom treatment drugs
Time frame: baseline/ week 2-4/ week 6-8/ week 12
Changes in body weight at the end of treatment compared with baseline
Time frame: baseline/ week 12
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 41847604Wei YM, Yang XD, Wang CS, Wang LL, Deng HL, Sang H, Xue AL, Zhu DM, Li YM, Liu XJ, Li HY, Shen YF; post-market surveillance investigators. Lurasidone in Schizophrenia Management: A Comprehensive 12-Week Post-Marketing Surveillance Study in Chinese Patients. Neuropsychiatr Dis Treat. 2026 Mar 12;22:588526. doi: 10.2147/NDT.S588526. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yifeng Xu principal investigator
Shanghai Mental Health Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Adverse Event (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04432688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.