NCT01614912

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2012

Typical duration for phase_3 schizophrenia

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

October 19, 2018

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

June 6, 2012

Results QC Date

July 20, 2017

Last Update Submit

April 9, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint

    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.

    DB baseline and up to 32 weeks (LOCF endpoint)

Secondary Outcomes (7)

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

    DB baseline and up to 32 weeks (LOCF endpoint)

  • Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint

    DB baseline and up to 32 weeks (LOCF endpoint)

  • Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint

    DB baseline and up to 32 weeks (LOCF endpoint)

  • Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint

    DB baseline and up to 32 weeks (LOCF endpoint)

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

    EXT baseline and up to 26 weeks

  • +2 more secondary outcomes

Study Arms (1)

SM-13496

EXPERIMENTAL
Drug: SM-13496

Interventions

SM-13496DRUG

40 or 80 mg once daily orally

SM-13496

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are considered by the investigator eligible for the present study with no significant safety concerns
  • Patients who are fully informed of and understand 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:

  • Patients who are planning pregnancy for the expected duration of the study
  • Patients who are otherwise considered ineligible for the study by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

69 Sites

Tokyo, Etc, Japan

Location

10 Sites

Kuala Lumpur, Etc, Malaysia

Location

22 Sites

Seoul, Etc, South Korea

Location

14Sites

Taipei, Etc, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

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)