SchizophreniaPhase 4NCT05011669

The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia

A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of Lurasidone initiated with 40mg and 80mg in treatment with acute phase patients with schizophrenia Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Lurasidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteChina
Study dates: 16 Aug 2021to 16 Jun 2023
Phase: Phase 4
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects meet ICD10 criteria for a primary diagnosis of schizophrenia;
Subjects have a score ≥ 4 on the CGI-S at Screening and Baseline;
Subjects have a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, with a score 4 (moderate) or higher in 2 or more items on the following PANSS items: delusions, conceptual disorganization, hallucinations, unusual thought content and suspiciousness;
Subjects with acute (including recurrence /relapse and first episode) phase patients with schizophrenia;
Ability to understand the contents of interview and provide written informed consent (If subject is unable to sign, subject's legal guardian or impartial witness shall sign the informed consent).

Who cannot join

Subjects with severe or unstable physical diseases (including but not limited to severe or unstable cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases) determined by the investigators;
Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications;
Based on the judgement of investigators, subject has a history of refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of baseline;
Subjects has used long-term antipsychotic drugs, e.g. Haloperidol decanoate injection, Fluphenazine decanoate injection, Risperidone microspheres injection, Paliperidone palmitate injection, Paliperidone palmitate injection (3M), in the following time prior to the enrolment;
Subjects is at risk of suicide or self-mutilation behaviours or the act of endangering others, or other corresponding characteristic behaviour, or a history of suicide;
Female subjects were pregnant (positive pregnancy test at screening) or breast-feeding or planning pregnancy for the duration of the study, or the partners of male subjects were planning pregnancy for the duration of the study;

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Need to use of disallowed concomitant therapy which is specified in the protocol;
History of severe allergy or hypersensitivity;
Currently has severe liver function impairment, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal value;
Creatinine clearance rate < 50mL/min Creatinine clearance rate*100%= Male: (140 - Age) x Weight(kg)/Serum creatinine (mg/dL) x 72 Female: 0.85*(140 - Age) x Weight(kg)/Serum creatinine (mg/dL) x 72
A history of malignant tumors (including benign pituitary tumors);
Any chronic organic disease of the central nervous system (excluding schizophrenia), such as CNS related tumors and inflammation, active seizures, vascular disease, Parkinson's disease, Alzheimer's disease, or other forms of dementia, myasthenia gravis, and other degenerative diseases. A history of mental retardation or persistent neurological symptoms caused by severe head injury;
Subjects received electroconvulsive therapy (ECT) within 90 days prior to screening, or were expected to require ECT during the study;
A history of neuroleptic malignant syndrome;
Severe tardive dyskinesia, severe dystonia, or any other severe dyskinesia;
Angioedema occurred after previous administration of lurasidone;
The subject is participating in or has participated in other clinical trials, including the use of commercially available drugs or medical devices, within 30 days prior to the signing of the informed consent;
Patients who had previously participated in a clinical study of lurasidone;
Any other conditions judged by the investigators that not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Sixth Hospital
Beijing, Beijing Municipality

Other trials in China

About this study

Official title: The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks

To evaluate the safety and efficacy of Lurasidone initiated with 40mg and 80mg in treatment with acute phase patients with schizophrenia

Conditions: Schizophrenia
Being tested: Lurasidone
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LurasidoneDrug
Oral administration with a meal or within 30 min after eating in the evening. The dosage could be adjusted from Day 8.

Study groups in NCT05011669
Study group	Role	What they receive
Latuda® 40mg/d	Experimental	Not described Receives: Drug: Lurasidone
Latuda® 80mg/d	Experimental	Not described Receives: Drug: Lurasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of discontinuation due to adverse events
Measured: during the 6 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202116 Jun 2023

First posted18 Aug 2021
Study start16 Aug 2021
Primary completion16 Apr 2023
Study completion16 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05011669
Sponsor's protocol ID: DSPCLAT-003
Status last verified: Apr 2024
First submitted: 7 Aug 2021
Last updated: 18 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
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All Schizophrenia trials

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 Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia: A Multi-Center, Prospective, Open-Label Study for 6 Weeks
ClinicalTrials.gov ID: NCT05011669
Acronym / sponsor ID: DSPCLAT-003
Conditions: Schizophrenia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Aug 2021 (actual)
Primary completion: 16 Apr 2023 (actual)
Study completion: 16 Jun 2023 (actual)
First posted: 18 Aug 2021 (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.

To evaluate the safety and efficacy of Lurasidone initiated with 40mg and 80mg in treatment with acute phase patients with schizophrenia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Latuda® 40mg/d	Experimental	Drug: Lurasidone
Latuda® 80mg/d	Experimental	Drug: Lurasidone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects meet ICD10 criteria for a primary diagnosis of schizophrenia;
Subjects have a score ≥ 4 on the CGI-S at Screening and Baseline;
Subjects have a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, with a score 4 (moderate) or higher in 2 or more items on the following PANSS items: delusions, conceptual disorganization, hallucinations, unusual thought content and suspiciousness;
Subjects with acute (including recurrence /relapse and first episode) phase patients with schizophrenia;
Ability to understand the contents of interview and provide written informed consent (If subject is unable to sign, subject's legal guardian or impartial witness shall sign the informed consent).

Key exclusion criteria (19 listed)

Subjects with severe or unstable physical diseases (including but not limited to severe or unstable cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases) determined by the investigators;
Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications;
Based on the judgement of investigators, subject has a history of refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of baseline;
Subjects has used long-term antipsychotic drugs, e.g. Haloperidol decanoate injection, Fluphenazine decanoate injection, Risperidone microspheres injection, Paliperidone palmitate injection, Paliperidone palmitate injection (3M), in the following time prior to the enrolment;
Subjects is at risk of suicide or self-mutilation behaviours or the act of endangering others, or other corresponding characteristic behaviour, or a history of suicide;

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
LurasidoneOral administration with a meal or within 30 min after eating in the evening. The dosage could be adjusted from Day 8.	Drug	Latuda® 40mg/d, Latuda® 80mg/d

Primary outcome

Percentage of discontinuation due to adverse events
Time frame: during the 6 weeks of treatment

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.

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.
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site 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 5 inclusion and 19 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 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of discontinuation due to adverse events (time frame: during the 6 weeks of treatment). 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 NCT05011669.

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.