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A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986114
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : July 23, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 18, 2013
Results First Submitted Date  ICMJE May 19, 2019
Results First Posted Date  ICMJE July 23, 2019
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE January 29, 2014
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR) [ Time Frame: 28, 52 weeks ]
The number and percentage of subjects with at least one adverse event and adverse drug reaction
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline, 52 weeks and each month ]
    Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
  • Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score. [ Time Frame: Baseline, 52 weeks and each month ]
    YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items.
  • Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder. [ Time Frame: Baseline to 52 weeks ]
    The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: Baseline, 52 weeks and each month ]
  • Change from baseline in the Young Mania Rating Scale (YMRS) total score. [ Time Frame: Baseline, 52 weeks and each month ]
  • The time to recurrence/relapse of any mood event from clinical stability of bipolar disorder. [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Official Title  ICMJE A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Brief Summary The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
Detailed Description The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar I Disorder
Intervention  ICMJE Drug: SM-13496
Other Name: Lurasidone
Study Arms  ICMJE Experimental: SM-13496 20-120mg
once daily orally SM-13496 20-120 mg flexibly dosed
Intervention: Drug: SM-13496
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2019)
495
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2013)
405
Actual Study Completion Date  ICMJE February 17, 2018
Actual Primary Completion Date February 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients who completed the D1002001 study

・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.

Patients who did not participate in the D1002001 study

  • Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
  • Outpatients aged 18 through 74 years at the time of consent
  • Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).

Exclusion Criteria:

  • Patients with imminent risk of suicide or injury to self, others, or property.
  • Patients who are otherwise considered ineligible for the study by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Lithuania,   Malaysia,   Philippines,   Russian Federation,   Slovakia,   Taiwan,   Ukraine
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT01986114
Other Study ID Numbers  ICMJE D1002002
JapicCTI-132319 ( Registry Identifier: JAPIC Clinical Trials Information )
2013-003039-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sumitomo Dainippon Pharma Co., Ltd.
Study Sponsor  ICMJE Sumitomo Dainippon Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Director, Drug Development Division Sumitomo Dainippoon Pharma
PRS Account Sumitomo Dainippon Pharma Co., Ltd.
Verification Date May 2019

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