A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
NCT ID: NCT01986101
Last Updated: 2022-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
525 participants
INTERVENTIONAL
2014-02-19
2017-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
once daily orally
Placebo
Placebo comparator
SM-13496 20 - 60 mg/day
once daily orally
SM-13496
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
SM-13496 80 - 120 mg/day
once daily orally
SM-13496
SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Interventions
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Placebo
Placebo comparator
SM-13496
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
SM-13496
SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatients aged 18 through 74 years at the time of consent
* Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Exclusion Criteria
* Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
* 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 76 sites
Tokyo, , Japan
Lithuania 3 sites
Kaunas, , Lithuania
Malaysia 5 sites
Kuala Lumpur, , Malaysia
Philippines 4 sites
Manila, , Philippines
Russia 19 sites
Moscow, , Russia
Slovakia 5 sites
Žilina, , Slovakia
Taiwan 7 sites
Taipei, , Taiwan
Ukraine 9 sites
Kiev, , Ukraine
Countries
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References
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Kato T, Ishigooka J, Miyajima M, Watabe K, Fujimori T, Masuda T, Higuchi T, Vieta E. Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression. Psychiatry Clin Neurosci. 2020 Dec;74(12):635-644. doi: 10.1111/pcn.13137. Epub 2020 Sep 24.
Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
Kishi T, Nakamura H, Kato T, Iwata N. A diagnostic test to examine early improvement as a predictor of later response to lurasidone in bipolar depression. Neuropsychopharmacol Rep. 2023 Mar;43(1):137-140. doi: 10.1002/npr2.12319. Epub 2023 Jan 12.
Kishi T, Yoshimura R, Sakuma K, Okuya M, Iwata N. Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan. Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-132318
Identifier Type: REGISTRY
Identifier Source: secondary_id
2013-003038-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1002001
Identifier Type: -
Identifier Source: org_study_id
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