A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia
NCT ID: NCT01451164
Last Updated: 2019-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
459 participants
INTERVENTIONAL
2011-10-31
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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High dose
OPC-34712
orally administered once daily
Mid dose
OPC-34712
orally administered once daily
Low dose
OPC-34712
orally administered once daily
Placebo
Placebo
orally administered once daily
Interventions
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OPC-34712
orally administered once daily
OPC-34712
orally administered once daily
OPC-34712
orally administered once daily
Placebo
orally administered once daily
Eligibility Criteria
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Inclusion Criteria
* Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
* Patients who are experiencing acute exacerbation of psychotic symptoms
Exclusion Criteria
* Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
* Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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kyoji Imaoka, Operating Officer
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Kanto Region, , Japan
Countries
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Other Identifiers
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JapicCTI-111631
Identifier Type: OTHER
Identifier Source: secondary_id
331-10-002
Identifier Type: -
Identifier Source: org_study_id
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