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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.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SM-13496 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
Study Start Date : August 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: SM-13496 Drug: SM-13496
40 or 80 mg once daily orally




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Proportion of Participants With TEAEs Leading to Discontinuation [ Time Frame: EXT baseline and up to 26 weeks ]
  7. 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.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614912


Locations
Japan
69 Sites
Tokyo, Etc, Japan
Korea, Republic of
22 Sites
Seoul, Etc, Korea, Republic of
Malaysia
10 Sites
Kuala Lumpur, Etc, Malaysia
Taiwan
14Sites
Taipei, Etc, Taiwan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01614912     History of Changes
Other Study ID Numbers: D1001057
JapicCTI-121860 ( Registry Identifier: JAPIC Clinical Traials Information )
First Posted: June 8, 2012    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: July 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents