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

NCT01614899 | Completed Phase 3 Results

• 2 other identifiers: D1001056JapicCTI-121859
• Study Type: interventional
• Target: 457
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6

  Baseline and 6 weeks

• Change From Baseline in PANSS Positive Subscale Scores at Week 6

  Baseline and 6 weeks

• Change From Baseline in PANSS Negative Subscale Scores at Week 6

  Baseline and 6 weeks

• Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6

  Baseline and 6 weeks

• Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)

  From Baseline to 6 weeks

Study Arms (3)

SM-13496 40mg

EXPERIMENTAL

Drug: SM-13496 40mg

SM-13496 80mg

EXPERIMENTAL

Drug: SM-13496 80mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SM-13496 40mg DRUG

once daily orally

SM-13496 40mg

SM-13496 80mg DRUG

once daily orally

SM-13496 80mg

Placebo DRUG

once daily orally

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (4)

69 Sites

Tokyo, Etc, Japan

Location

10 Sites

Kuala Lumpur, Etc, Malaysia

Location

22 Sites

Seoul, Etc, South Korea

Location

14 Sites

Taipei, Etc, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Regional Function Head of CNS Research
• Organization: Clinical Research, Drug Development Division

cc@ds-pharma.co.jp

+81-3-5159-2519

Study Officials

• Clinical Development Drug development Division

  Sumitomo Pharma Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: July 2, 2012
• Primary Completion: November 17, 2014
• Study Completion: November 17, 2014
• Last Updated: April 12, 2022
• Results First Posted: October 19, 2018

Record last verified: 2022-04

Locations

MY (1); TW (1); JP (1); KR (1)