SchizophreniaPhase 4NCT03393026
A Study of Lurasidone HCl in Subjects With Schizophrenia
A Phase 4 study testing Lurasidone in people with Schizophrenia, run by Standard Chem. & Pharm. Co., Ltd. at 2 sites in Taiwan.
Trial summary
The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesTaiwan
- Study dates
- 3 Jan 2018to 17 Sep 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or female aged at 20-75 years old
- Subjects who are diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- CGI-S≦4 (at both screening and baseline)
- Subject is judged by the investigator to have been clinically stable for at least 4 weeks prior to baseline and in need for a switch from their current antipsychotic treatment due to insufficient clinical response or poor tolerability (side effects, metabolic complications, etc.).
- If the subject recruits from OPD, the subject should be intolerant to the AE or is insufficient in current antipsychotics treatment by investigator's judgment.
- Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
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- Subject is able and agrees to remain off (or stable dosage) prior antipsychotic medication during the study period as defined by this protocol.
- In the Investigator's opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
- Subject is willing and able to comply with the protocol.
Who cannot join
- Subject has clinically substantial risk of suicide or violent behavior as judged by the investigator.
- Subject with the past history of neuroleptic malignant syndrome, water intoxication, paralytic ileus or dementia related psychosis
- Subjects is active pregnancy (must have a negative pregnancy test at screening) or nursing (must not be lactating).
- Subject has received treatment with MAO inhibitors within 14 days prior to the screening (Visit 1).
- Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 1 month prior to signing the informed consent.
- Subject is unstable or critical untreated medical illness by the judgment of investigators.
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- Subject who is otherwise considered ineligible for the study by investigator. For example, subjects experienced serious medical condition including known clinically relevant laboratory abnormalities, and hypersensitivity to Lurasidone.
- Subjects who were considered resistance to treatment for psychotic symptoms by the investigator.
- Total daily dose of pre-switch antipsychotic was exceeded the equivalent of haloperidol 12 mg/day.
- Subjects have received long depot neuroleptics within 4 weeks prior to enrollment. Or, subject was treated with clozapine for refractory psychosis within 1 month of enrollment.
- Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study. Subject requires treatment with a drug that consistently prolongs the QTc interval.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei City Hospital, Songde Branch
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia
The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks.
- 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 40-160 mg/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone 40-160 mg | Experimental | Lurasidone 40-160 mg Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure.
Treatment failure is defined as any occurrence of: Insufficient clinical response Exacerbation of underlying disease Discontinuation due to adverse event
Measured: 6 weeks
Secondary outcomes (3)
Positive and Negative Syndrome Scale(PANSS) total scores
" Mean Change from baseline at week 6" in Positive and Negative Syndrome Scale total scores.
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item.The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity
Measured: 6 weeks
Clinical Global Impression-Improvement (CGI-I) Scale
" Mean Change from baseline at week 6" in Clinical Global Impression-Improvement.
The CGI-I Score is a clinician-rated assessment of the subject's overall clinical condition. The CGI-I score obtained at the baseline (initiation) visit serves as a good basis for making this assessment. This subject's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Measured: 6 weeks
Clinical Global Impression-Severity (CGI-S)
" Mean Change from baseline at week 6" in Clinical Global Impression-Severity.
The CGI-S Score is a clinician-rated assessment of the subject's current illness state on a 7-point scale (1-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start3 Jan 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
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
- Model description
- Lurasidone 40-160 mg/day
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Chem. & Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393026
- Sponsor's protocol ID
- SCPF20L01TW
- Status last verified
- Feb 2020
- First submitted
- 20 Dec 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Single Arm and Flexible Dose Study of the Effectiveness and Safety of Oral Use Lurasidone HCl Tablet (LATUDA®) for 40-160 mg/Day in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT03393026
- Acronym / sponsor ID
- SCPF20L01TW
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Standard Chem. & Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 8 Jan 2018 (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.
The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia over a period of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lurasidone 40-160 mg/day
| Arm | Type | Receives |
|---|---|---|
| Lurasidone 40-160 mg | Experimental | Drug: LurasidoneLurasidone 40-160 mg |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or female aged at 20-75 years old
- Subjects who are diagnosed with schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- CGI-S≦4 (at both screening and baseline)
- Subject is judged by the investigator to have been clinically stable for at least 4 weeks prior to baseline and in need for a switch from their current antipsychotic treatment due to insufficient clinical response or poor tolerability (side effects, metabolic complications, etc.).
- If the subject recruits from OPD, the subject should be intolerant to the AE or is insufficient in current antipsychotics treatment by investigator's judgment.
Key exclusion criteria (11 listed)
- Subject has clinically substantial risk of suicide or violent behavior as judged by the investigator.
- Subject with the past history of neuroleptic malignant syndrome, water intoxication, paralytic ileus or dementia related psychosis
- Subjects is active pregnancy (must have a negative pregnancy test at screening) or nursing (must not be lactating).
- Subject has received treatment with MAO inhibitors within 14 days prior to the screening (Visit 1).
- Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 1 month prior to signing the informed consent.
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 40-160 mg/day for 6 weeks | Drug | Lurasidone 40-160 mg |
Primary outcome
time to treatment failure.
Time frame: 6 weeks
Treatment failure is defined as any occurrence of: Insufficient clinical response Exacerbation of underlying disease Discontinuation due to adverse event
3 secondary outcomes
Positive and Negative Syndrome Scale(PANSS) total scores
Time frame: 6 weeks
Clinical Global Impression-Improvement (CGI-I) Scale
Time frame: 6 weeks
Clinical Global Impression-Severity (CGI-S)
Time frame: 6 weeks
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 5 Feb 2020.
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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.
2 sites 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 Standard Chem. & Pharm. Co., Ltd. at 2 sites in Taiwan.
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 11 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
time to treatment failure. (time frame: 6 weeks). 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 5 Feb 2020.