A Clinical Trial of Lurasidone in Treatment of Schizophrenia
NCT ID: NCT02002832
Last Updated: 2019-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2013-12-31
2015-11-30
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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Lurasidone group
Lurasidone tablets
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Risperidone group
Risperidone tablets
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Interventions
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Lurasidone tablets
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Risperidone tablets
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
* Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion Criteria
* Any chronic organic disease of the CNS(other than schizophrenia)
* Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
18 Years
65 Years
ALL
No
Sponsors
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Sumitomo Pharma (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhuoji CAI, MD
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University Affiliated Beijing Anding Hospital
Locations
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Capital Medical University Affiliated Beijing Anding Hospital
Beijing, Beijing Municipality, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Beijing, Beijing Municipality, China
Guangzhou Brain Hospital
Guangzhou, Guangdong, China
HeBei Mental Health Center
Baoding, Hebei, China
Henan Provincial Mental Hospital
Xinxiang, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Province Brain Hospital
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Xi'an Mental Health Center
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Other Identifiers
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D1070004
Identifier Type: -
Identifier Source: org_study_id
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