A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
NCT ID: NCT01986114
Last Updated: 2022-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
495 participants
INTERVENTIONAL
2014-01-29
2018-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SM-13496 20-120mg
once daily orally SM-13496 20-120 mg flexibly dosed
SM-13496
Interventions
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SM-13496
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
・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 who are otherwise considered ineligible for the study by the investigator.
18 Years
74 Years
ALL
No
Sponsors
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Sumitomo Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Director, Drug Development Division
Role: STUDY_DIRECTOR
Sumitomo Pharma Co., Ltd.
Locations
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Japan 68 sites
Tokyo, , Japan
Lithuania 3 sites
Kaunas, , Lithuania
Malaysia 5 sites
Kuala Lumpur, , Malaysia
Philippines 5 sites
Manila, , Philippines
Russia 19 sites
Moscow, , Russia
Slovakia 5 sites
Žilina, , Slovakia
Taiwan 8 sites
Taipei, , Taiwan
Ukraine 9 sites
Kiev, , Ukraine
Countries
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References
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Higuchi T, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Ishigooka J. Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study. Int J Bipolar Disord. 2021 Aug 2;9(1):25. doi: 10.1186/s40345-021-00230-8.
Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, Hagi K, Higuchi T. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021 Feb 15;281:160-167. doi: 10.1016/j.jad.2020.12.005. Epub 2020 Dec 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-132319
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-003039-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1002002
Identifier Type: -
Identifier Source: org_study_id
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