Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2011-06-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lurasidone
Lurasidone flexibly dosed
Lurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Interventions
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Lurasidone
Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Eligibility Criteria
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Inclusion Criteria
* The subject has completed the extension phase of a prior lurasidone clinical study. Eligible subjects may enroll into this continuation study directly (or within 10 days) after completing the extension phase of a prior lurasidone clinical study. Subjects that have completed an extension study prior to the initiation of this protocol at the study site, may participate in this study up to 3 months after completion of the extension phase of the prior lurasidone study.
* The subject is judged by the Investigator to be suitable for participation in a clinical study involving open-label lurasidone treatment and is able to comply with the protocol.
* The subject, in the Investigator's judgment, may benefit from continued treatment with lurasidone
Exclusion Criteria
* The subject resides in a country where lurasidone has been approved for any indication.
* The subject is currently enrolled in any other investigational study.
* The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations
Barranquilla, , Colombia
E.S.E. Hospital Mental de Antioquia
Bello, , Colombia
CISNE - UIC Campo Abierto
Bogotá, , Colombia
Psychiatricka ambulance
Brno-mesto, , Czechia
Vojenska nemocnice Olomouc
Olomouc, , Czechia
Clintrial, s.r.o.
Prague, , Czechia
Psychiatry Trial s.r.o.
Prague, , Czechia
Medical Services Prague s.r.o.
Prague, , Czechia
Zans Ritter, Marcel
Orvault, , France
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
Toulun, , France
Brain Mind Behavior Neuroscience Research Institute
Visakhapatnam, Andh Prad, India
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, India
Samvedna Hospitals
Ahmedabad, Gujarat, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, India
Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry
Ahmedabad, Gujarat, India
Hatkesh Healthcare Foundation
Jūnāgadh, Gujarat, India
Brij Psychiatry Hospital & Muskaan Research Centre
Vadodara, Gujarat, India
Shanti Nursing Home
Aurangabad, Maharashtra, India
Dr. Tambi's Neuropsychiatry Center
Jaipur, Rajaasthan, India
R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry
Jaipur, Rajasthan, India
Mahendru Psychiatric Centre
Kanpur, , India
Neuromeda JSC
Kaunas, , Lithuania
JSC Neuromeda
Kaunas, , Lithuania
Seskines Outpatient Clinic, Public Institution
Vilnius, , Lithuania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, , Romania
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, , Romania
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
Lipetsk, , Russia
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1
Saint Petersburg, , Russia
St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
Saint Petersburg, , Russia
Institute of Mental Health
Belgrade, , Serbia
Clinical Centre Nis, Clinic for mental health protection
Niš, , Serbia
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, , Slovakia
PsychoLine s.r.o. Psychiatricka ambulancia
Rimavská Sobota, , Slovakia
Centrum zdravia R.B.K. s.r.o. Psychiatricka ambulancia
Svidník, , Slovakia
Pro mente sana s.r.o. Psychiaricka ambulancia
Trenčín, , Slovakia
Dey Clinic
Pretoria, Gauteng, South Africa
Cape Trial Centre
Tygervalley, Western Cape, South Africa
Denmar Hospital Consulting Rooms
Pretoria, , South Africa
Kherson Regional Psychiatric Hospital
Kherson, Vil Stepanivka, Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, , Ukraine
Regional Clinical Psychiatric Hospital, Dept #11
Donetsk, , Ukraine
Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine
Khardov, , Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, , Ukraine
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Vinnitsia, , Ukraine
Countries
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Other Identifiers
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2011-000682-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050298
Identifier Type: -
Identifier Source: org_study_id