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

NCT00711269 | Completed Phase 3 Results

• 2 other identifiers: D1001002JapicCTI-080585
• Study Type: interventional
• Target: 460
• Locations: 3 countries
• Sites: 3

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 (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.

  Baseline and Week 6 [Last Observation Carried Forward (LOCF)]

Secondary Outcomes (6)

• Change From Baseline in the PANSS Positive Subscales at Week 6 (LOCF)

  Baseline and Week 6 (LOCF)

• Change From Baseline in the PANSS Negative Subscales at Week 6

  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 TEAEs Leading to Discontinuation

  From Baseline to up to 8 weeks

Study Arms (4)

SM-13496 (lurasidone HCl) 40mg

EXPERIMENTAL

SM-13496 40 mg was administered orally once daily.

Drug: SM-13496 (lurasidone HCl)

SM-13496 (lurasidone HCl) 80mg

EXPERIMENTAL

SM-13496 80mg was administered orally once daily.

Drug: SM-13496 (lurasidone HCl)

Placebo

PLACEBO COMPARATOR

Placebo was administered orally twice daily.

Drug: Placebo

Risperidone

ACTIVE COMPARATOR

Risperidone was administered orally twice daily.

Drug: Risperidone

Interventions

SM-13496 (lurasidone HCl) DRUG

Lurasidone HCl: 40 mg/day

SM-13496 (lurasidone HCl) 40mg

Placebo DRUG

Placebo

Risperidone DRUG

Risperidone

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 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.

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 (3)

Japan: 67 sites

Tokyo, Etc., Japan

Location

Korea: 14 sites

Seoul, Etc., South Korea

Location

Taiwan: 11 sites

Taipei, Etc., Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride; Risperidone

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; Pyrimidinones; Pyrimidines

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

• 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 11, 2008
• First Posted: July 8, 2008
• Study Start: June 27, 2008
• Primary Completion: April 27, 2010
• Study Completion: April 27, 2010
• Last Updated: April 12, 2022
• Results First Posted: October 19, 2018

Record last verified: 2022-04

Locations

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