Adults 18 to 74, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6Primary· Baseline and 6 week
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 oth
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
-17.9
± 1.72
SM-13496 (Lurasidone HCl) 80mg
-17.3
± 1.67
Placebo
-13.1
± 1.72
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6Secondary· Baseline and 6 weeks
CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease.
The change from baseline in CGI-S score (repeated measures) at each visit during the treatment phase is presented for the mITT population
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
-0.86
± 0.100
SM-13496 (Lurasidone HCl) 80mg
-0.97
± 0.097
Placebo
-0.79
± 0.101
Change From Baseline in PANSS Positive Subscale Scores at Week 6Secondary· Baseline and 6 weeks
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.
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
-5.4
± 0.54
SM-13496 (Lurasidone HCl) 80mg
-6.2
± 0.52
Placebo
-4.2
± 0.54
Change From Baseline in PANSS Negative Subscale Scores at Week 6Secondary· Baseline and 6 weeks
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.
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
-3.9
± 0.46
SM-13496 (Lurasidone HCl) 80mg
-3.4
± 0.45
Placebo
-2.9
± 0.46
Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6Secondary· Baseline and 6 weeks
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.
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
-8.8
± 0.85
SM-13496 (Lurasidone HCl) 80mg
-7.9
± 0.83
Placebo
-6.3
± 0.85
Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)Secondary· From Baseline to 6 weeks
Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. 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.
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
103
SM-13496 (Lurasidone HCl) 80mg
107
Placebo
97
Proportion of Participants With TEAEs Leading to DiscontinuationSecondary· From Baseline to 6 weeks
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
11
SM-13496 (Lurasidone HCl) 80mg
11
Placebo
16
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)Secondary· From Baseline to 6 weeks
Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that 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 hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or migh
Group
Value
95% CI
SM-13496 (Lurasidone HCl) 40mg
4
SM-13496 (Lurasidone HCl) 80mg
3
Placebo
3
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline to 6 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
SM-13496 (Lurasidone HCl) 40mg
Serious: 4/150 (3%)
Deaths: —
SM-13496 (Lurasidone HCl) 80mg
Serious: 3/154 (2%)
Deaths: —
Placebo
Serious: 3/151 (2%)
Deaths: —
Serious adverse events (4 terms)
Reaction
System
SM-13496 (Lurasidone HCl) …
SM-13496 (Lurasidone HCl) …
Placebo
Schizophrenia
Psychiatric disorders
—
—
—
Femoral neck fracture
Injury, poisoning and procedural complications
—
—
—
Anxiety
Psychiatric disorders
—
—
—
Psychotic disorder
Psychiatric disorders
—
—
—
Other adverse events (208 terms — click to expand)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sumitomo Pharma Co., Ltd.
Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01614899.