SchizophreniaPhase 3NCT00711269
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
A Phase 3 study testing SM-13496 (lurasidone HCl) and Risperidone in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 3 sites in 3 countries.
Trial summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SM-13496 (lurasidone HCl) and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 27 Jun 2008to 27 Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patient meets DSM-IV criteria for schizophrenia.
- Patient is 18 or older but younger than 75 years of age on the day of signing informed consent.
- Patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent.
Main Exclusion Criteria:
- Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
- Patient has Parkinson's disease.
- Patient has a history or complication of malignancy.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- SM-13496 (lurasidone HCl), Placebo, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-13496 (lurasidone HCl)Drug
Lurasidone HCl: 40 mg/day
SM-13496 (lurasidone HCl)Drug
Lurasidone HCl: 80 mg/day
PlaceboDrug
RisperidoneDrug
| Study group | Role | What they receive |
|---|---|---|
| SM-13496 (lurasidone HCl) 40mg | Experimental | SM-13496 40 mg was administered orally once daily. Receives: Drug: SM-13496 (lurasidone HCl) |
| SM-13496 (lurasidone HCl) 80mg | Experimental | SM-13496 80mg was administered orally once daily. Receives: Drug: SM-13496 (lurasidone HCl) |
| Placebo | Placebo comparator | Placebo was administered orally twice daily. Receives: Drug: Placebo |
| Risperidone | Active comparator | Risperidone was administered orally twice daily. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. 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: Baseline and Week 6 [Last Observation Carried Forward (LOCF)]
Secondary outcomes (6)
Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)
The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. 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 Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Measured: Baseline and Week 6 (LOCF)
Change From Baseline in the PANSS Negative Subscales at Week 6
The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. 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 Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Measured: Baseline and Week 6 (LOCF)
Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)
The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. 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 General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.
Measured: Baseline and Week 6 (LOCF)
Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a study participant who was taking a medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.
Measured: From Baseline to up to 8 weeks
Proportion of Participants With TEAEs Leading to Discontinuation
Measured: From Baseline to up to 8 weeks
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Proportion of participants with treatment-emergent adverse events. An adverse event was considered serious if it met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Was considered to be an important medical event.
Measured: From Baseline to up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study start27 Jun 2008
- Primary completion27 Apr 2010
- Study completion27 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Drug Development Division, Study director, Sumitomo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711269
- Sponsor's protocol ID
- D1001002
- Other IDs
- JapicCTI-080585
- Status last verified
- Apr 2022
- First submitted
- 11 Jun 2008
- Last updated
- 12 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>
- ClinicalTrials.gov ID
- NCT00711269
- Acronym / sponsor ID
- D1001002
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2008 (actual)
- Primary completion
- 27 Apr 2010 (actual)
- Study completion
- 27 Apr 2010 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 19 Oct 2018
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 efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SM-13496 (lurasidone HCl) 40mg | Experimental | Drug: SM-13496 (lurasidone HCl)SM-13496 40 mg was administered orally once daily. |
| SM-13496 (lurasidone HCl) 80mg | Experimental | Drug: SM-13496 (lurasidone HCl)SM-13496 80mg was administered orally once daily. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered orally twice daily. |
| Risperidone | Active comparator | Drug: RisperidoneRisperidone was administered orally twice daily. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SM-13496 (lurasidone HCl)Lurasidone HCl: 40 mg/day | Drug | SM-13496 (lurasidone HCl) 40mg |
| SM-13496 (lurasidone HCl)Lurasidone HCl: 80 mg/day | Drug | SM-13496 (lurasidone HCl) 80mg |
| Placebo | Drug | Placebo |
| Risperidone | Drug | Risperidone |
Primary outcome
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)
Time frame: Baseline and Week 6 [Last Observation Carried Forward (LOCF)]
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. 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.
6 secondary outcomes
Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)
Time frame: Baseline and Week 6 (LOCF)
Change From Baseline in the PANSS Negative Subscales at Week 6
Time frame: Baseline and Week 6 (LOCF)
Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)
Time frame: Baseline and Week 6 (LOCF)
Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline to up to 8 weeks
Proportion of Participants With TEAEs Leading to Discontinuation
Time frame: From Baseline to up to 8 weeks
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: From Baseline to up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Drug Development Division study director
Sumitomo Pharma Co., Ltd.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SM-13496 (lurasidone HCl) and Risperidone in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, South Korea, 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF) (time frame: Baseline and Week 6 [Last Observation Carried Forward (LOCF)]). 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 12 Apr 2022.