A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SM-13496 40mg; Drug: SM-13496 80mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Etc, Japan
    • 69 Sites
• Korea, Republic of
  • Seoul, Etc, Korea, Republic of
    • 22 Sites
• Malaysia
  • Kuala Lumpur, Etc, Malaysia
    • 10 Sites
• Taiwan
  • Taipei, Etc, Taiwan
    • 14 Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient meets DSM-IV-TR criteria for schizophrenia.
• Patient is aged 18 through 74 years at informed consent.
• Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; once daily orally
EXPERIMENTAL: SM-13496 40mg	Drug: SM-13496 40mg; once daily orally
EXPERIMENTAL: SM-13496 80mg	Drug: SM-13496 80mg; once daily orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6	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.	Baseline and 6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6	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	Baseline and 6 weeks
Change From Baseline in PANSS Positive Subscale Scores at Week 6	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.	Baseline and 6 weeks
Change From Baseline in PANSS Negative Subscale Scores 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.	Baseline and 6 weeks
Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6	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.	Baseline and 6 weeks
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 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.	From Baseline to 6 weeks
Proportion of Participants With TEAEs Leading to Discontinuation		From Baseline to 6 weeks
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)	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 might require medical intervention to prevent one of the outcomes listed above.	From Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Sumitomo Pharma Co., Ltd.
• Investigators: Study Director: Clinical Development Drug development Division, Sumitomo Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 2, 2012
• Primary Completion (ACTUAL): November 17, 2014
• Study Completion (ACTUAL): November 17, 2014

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (ESTIMATE): June 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: D1001056; JapicCTI-121859 (REGISTRY: JAPIC Clinical Traials Information)