Randomized, Placebo-controlled, Double-blind, Parallel-group, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase III Study>
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Enrollment
- 460
- Locations
- 3
- Primary Endpoint
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (LOCF)
Study Overview
Brief Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
SM-13496 (lurasidone HCl) 40mg
SM-13496 40 mg was administered orally once daily.
Intervention: SM-13496 (lurasidone HCl) (Drug)
SM-13496 (lurasidone HCl) 80mg
SM-13496 80mg was administered orally once daily.
Intervention: SM-13496 (lurasidone HCl) (Drug)
Placebo
Placebo was administered orally twice daily.
Intervention: Placebo (Drug)
Risperidone
Risperidone was administered orally twice daily.
Intervention: Risperidone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in the PANSS Negative Subscales at Week 6(Baseline and Week 6 (LOCF))
- Proportion of Participants With TEAEs Leading to Discontinuation(From Baseline to up to 8 weeks)
- Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)(Baseline and Week 6 (LOCF))
- Change From Baseline in the PANSS General Psychopathology Subscales at Week 6 (LOCF)(Baseline and Week 6 (LOCF))
- Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)(From Baseline to up to 8 weeks)
- Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)(From Baseline to up to 8 weeks)