SchizophreniaPhase 4NCT05213143
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine
A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
An open-label, single-arm and multi-center study for 16 weeks 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
- 13 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 18 Nov 2022
- 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
- Subject aged ≥ 18 to ≤ 65 years old
- Meet ICD-10 criteria for a primary diagnosis of schizophrenia， the duration must be at least one year
- Provide written informed consent (subject's legal guardian or impartial witness shall sign informed consent if the subject is unable to sign) and is willing and able to comply with the protocol in the opinion of the investigator.
- Considered to be an appropriate candidate for switching olanzapine due to safety or tolerability concerns
- Received Olanzapine monotherapy at a dose of 10 to 20mg/d for at least 8 weeks with a body mass index (BMI) ≥25kg/m2, the dose of olanzapine has been stable for at least 4 weeks prior to screening. Weight gain during current olanzapine therapy was verified in the subject history.
- Subject must meet the clinical stability as following criteria:
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- CGI-S ≤ 4 (at both Screening and Baseline)
- PANSS total score ≤ 70 at Screening and Baseline
- No exacerbation of schizophrenia has occurred for at least 8 weeks prior to screening
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.
- 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
- Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications
- More than 10% weight loss 3 months prior to the screening period
- A history of malignant tumors (including benign pituitary tumors)
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- 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 need to take any potent CYP3A4 inhibitor (e.g., ketoconazole, ritonavir, clarithromycin, ritonavir, voriconazole, Mibefradil) or inducer (e.g. rifampicin, avasimibe, St. John's Wort, phenytoin, carbamazepine), drugs for external use in dermatological patients are excluded
- Subject has a history of treatment with clozapine for 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 in the following time prior to the enrolment
- 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
- 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
- History of severe allergy or hypersensitivity;
- Angioedema occurred after previous administration of lurasidone;
- Patients who had previously participated in a clinical study 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;
- Any other conditions judged by the investigators that not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks
An open-label, single-arm and multi-center study for 16 weeks
Read the detailed description
An open-label, single-arm and multi-center study for 16 weeks, to study the improvement of weight gain in patients with schizophrenia who switched from olanzapine to lurasidone.
- 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
Lurasidone was oral administrated with a meal or within 30 min after eating in the evening. The maintenance dose of olanzapine from Day 0 to Day 6, than tapered until discontinuation from Day 7 to Day 27. Lurasidone initiated with 40mg/d on Day 0, maintained until Day 13, with a flexible dose (40-80mg/d, qd) from Day 28 to Day 111.
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone | Experimental | Lurasidone was oral administrated with a meal or within 30 min after eating in the evening. Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight change
Changes in body weight at the end of treatment compared to baseline
Measured: from baseline to week 16
Secondary outcomes (10)
Change in Positive and Negative Syndrome Scale (PANSS) scores
Change in PANSS scores at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in the Clinical Global Impressions-Severity (CGI-S) scores
Change in CGI-S scores at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in 12-Item Short Form Survey (SF-12) scores
Change in SF-12 scores at the end of treatment compared to baseline
Measured: from baseline to week 16
Change in waist circumference
Change in waist circumference at the end of treatment compared to baseline. Wrap the tape around 0.5 to 1.0 cm above the belly button, and measure the circumference.Obese patients wrap a tape measure around the widest part of their waist.
Measured: from baseline to week 16
Change in the serum prolactin (PRL)
Change in PRL at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in Calgary Depression Scale for Schizophrenia (CDSS) scores
Change in CDSS scores at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in fasting lipids
Change in fasting lipids（total cholesterol, triglycerides, high density liptein cholesterol, low density lipoprotein, Non-high density liptein cholesterol) at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in fasting plasma glucose
Change in fasting plasma glucose at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in hemoglobin A1c (HbA1c)
Change in HbA1c at the end of treatment compared to baseline.
Measured: from baseline to week 16
Change in the Epworth Sleepiness Scale
Change in the Epworth sleepiness scale at the end of treatment compared to baseline. A score of 10 or greater raises concern.
Measured: from baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start30 Dec 2021
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Why it stopped: Company's business decision
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213143
- Sponsor's protocol ID
- DSPC-LAT-002
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks
- ClinicalTrials.gov ID
- NCT05213143
- Acronym / sponsor ID
- DSPC-LAT-002
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company's business decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 28 Jan 2022 (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.
An open-label, single-arm and multi-center study for 16 weeks
Detailed description
An open-label, single-arm and multi-center study for 16 weeks, to study the improvement of weight gain in patients with schizophrenia who switched from olanzapine to lurasidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone | Experimental | Drug: LurasidoneLurasidone was oral administrated with a meal or within 30 min after eating in the evening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject aged ≥ 18 to ≤ 65 years old
- Meet ICD-10 criteria for a primary diagnosis of schizophrenia， the duration must be at least one year
- Provide written informed consent (subject's legal guardian or impartial witness shall sign informed consent if the subject is unable to sign) and is willing and able to comply with the protocol in the opinion of the investigator.
- Considered to be an appropriate candidate for switching olanzapine due to safety or tolerability concerns
- Received Olanzapine monotherapy at a dose of 10 to 20mg/d for at least 8 weeks with a body mass index (BMI) ≥25kg/m2, the dose of olanzapine has been stable for at least 4 weeks prior to screening. Weight gain during current olanzapine therapy was verified in the subject history.
Key exclusion criteria (20 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.
- 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
- Subjects had a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications
- More than 10% weight loss 3 months prior to the screening period
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 |
|---|---|---|
| LurasidoneLurasidone was oral administrated with a meal or within 30 min after eating in the evening. The maintenance dose of olanzapine from Day 0 to Day 6, than tapered until discontinuation from Day 7 to Day 27. Lurasidone initiated with 40mg/d on Day 0, maintained until Day 13, with a flexible dose (40-80mg/d, qd) from Day 28 to Day 111. | Drug | Lurasidone |
Primary outcome
Mean weight change
Time frame: from baseline to week 16
Changes in body weight at the end of treatment compared to baseline
10 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS) scores
Time frame: from baseline to week 16
Change in the Clinical Global Impressions-Severity (CGI-S) scores
Time frame: from baseline to week 16
Change in 12-Item Short Form Survey (SF-12) scores
Time frame: from baseline to week 16
Change in waist circumference
Time frame: from baseline to week 16
Change in the serum prolactin (PRL)
Time frame: from baseline to week 16
Change in Calgary Depression Scale for Schizophrenia (CDSS) scores
Time frame: from baseline to week 16
Change in fasting lipids
Time frame: from baseline to week 16
Change in fasting plasma glucose
Time frame: from baseline to week 16
Change in hemoglobin A1c (HbA1c)
Time frame: from baseline to week 16
Change in the Epworth Sleepiness Scale
Time frame: from baseline to week 16
Results and safety
The study was stopped early (reason given: Company's business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 19 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 was stopped early (reason given: Company's business decision). Results are not available in the source record.
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?
Mean weight change (time frame: from baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.