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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.

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: SM-13496 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Actual Study Start Date : January 29, 2014
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: SM-13496 20-120mg
once daily orally SM-13496 20-120 mg flexibly dosed
Drug: SM-13496
Other Name: Lurasidone




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



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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 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.

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): NCT01986114


Locations
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Japan
Japan 68 sites
Tokyo, Japan
Lithuania
Lithuania 3 sites
Kaunas, Lithuania
Malaysia
Malaysia 5 sites
Kuala Lumpur, Malaysia
Philippines
Philippines 5 sites
Manila, Philippines
Russian Federation
Russia 19 sites
Moscow, Russian Federation
Slovakia
Slovakia 5 sites
Zilina, Slovakia
Taiwan
Taiwan 8 sites
Taipei, Taiwan
Ukraine
Ukraine 9 sites
Kiev, Ukraine
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
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Study Director: Director, Drug Development Division Sumitomo Dainippoon Pharma
  Study Documents (Full-Text)

Documents provided by Sumitomo Dainippon Pharma Co., Ltd.:
Study Protocol  [PDF] March 15, 2016
Statistical Analysis Plan  [PDF] March 20, 2018


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Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01986114     History of Changes
Other Study ID Numbers: D1002002
JapicCTI-132319 ( Registry Identifier: JAPIC Clinical Trials Information )
2013-003039-31 ( EudraCT Number )
First Posted: November 18, 2013    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: August 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Disease
Pathologic Processes
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