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

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ClinicalTrials.gov Identifier: NCT01614912
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

June 6, 2012
June 8, 2012
July 20, 2017
October 19, 2018
October 19, 2018
August 2012
May 2015   (Final data collection date for primary outcome measure)
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint [ Time Frame: DB baseline and up to 32 weeks (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.
Change from baseline in PANSS total score [ Time Frame: Change from baseline ]
Complete list of historical versions of study NCT01614912 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint [ Time Frame: DB baseline and up to 32 weeks (LOCF endpoint) ]

    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.

    Baseline in the prior study (D1001056, double-blind [DB] baseline) was defined as baseline of the prior study. Baseline in the present study (D1001057, extension [EXT] baseline) was defined as Week 6 in the prior study.

    The last post-baseline visit data collected during the study treatment of the present study were carried forward and defined as the last observation carried forward (LOCF) endpoint.

  • Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint [ Time Frame: DB baseline and up to 32 weeks (LOCF endpoint) ]
    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.
  • Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint [ Time Frame: DB baseline and up to 32 weeks (LOCF endpoint) ]
    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.
  • Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint [ Time Frame: DB baseline and up to 32 weeks (LOCF endpoint) ]
    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.
  • Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: EXT baseline and up to 26 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 are defined as adverse events with a start date on or after the date of initial administration of study drug in the present study through the end of follow-up or adverse events occurring before the date of initial administration of study drug in the present study and worsening during the study treatment in the present study.
  • Proportion of Participants With TEAEs Leading to Discontinuation [ Time Frame: EXT baseline and up to 26 weeks ]
  • Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: EXT baseline and up to 26 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 might require medical intervention to prevent one of the outcomes listed above.
Not Provided
Not Provided
Not Provided
 
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: SM-13496
40 or 80 mg once daily orally
Experimental: SM-13496
Intervention: Drug: SM-13496
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
435
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who are planning pregnancy for the expected duration of the study
  • Patients who are otherwise considered ineligible for the study by the investigator
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Malaysia,   Taiwan
 
 
NCT01614912
D1001057
JapicCTI-121860 ( Registry Identifier: JAPIC Clinical Traials Information )
No
Not Provided
Not Provided
Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma Co., Ltd.
Not Provided
Not Provided
Sumitomo Dainippon Pharma Co., Ltd.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP