A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
NCT ID: NCT01566162
Last Updated: 2019-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
191 participants
INTERVENTIONAL
2012-04-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lurasidone
Lurasidone 40 - 80mg flexible dose
Lurasidone
Lurasidone 40-80 mg taken orally taken once daily
Interventions
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Lurasidone
Lurasidone 40-80 mg taken orally taken once daily
Eligibility Criteria
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Inclusion Criteria
* Subject will be eligible to participate if one of the following criteria is met:
* Subject has completed the 28-week double-blind phase of study D1050238
* Subject has experienced a protocol-defined relapse event during the double- blind phase in study D1050238
* Subject is participating in the open-label or double-blind phase of study D1050238 if/when study D1050238 is terminated by the sponsor.
* Subject has completed all required assessments on the final study visit (Study Visit Number 42) in study D1050238.
* Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion Criteria
* Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit Number 42 in study D1050238). Subjects who answer "yes" to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment.
* Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a subject tests positive for cannabinoids, the Investigator will evaluate the subject's ability to abstain from cannabis during the study.
18 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lurasidone Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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K and S Professional Research Services
Little Rock, Arkansas, United States
Woodland International Research Inc.
Little Rock, Arkansas, United States
Comprehensive Clinical Development Inc.
Cerritos, California, United States
Diligent Clinical Trials
Downey, California, United States
Synergy Clinical Research Center
Escondido, California, United States
CNS Network
Garden Grove, California, United States
AXIS Clinical Trials
Los Angeles, California, United States
Synergy Clinical Research Center
National City, California, United States
Excell Research, Inc.
Oceanside, California, United States
CNRI-Los Angeles. LLC
Pico Rivera, California, United States
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Collaborative Neuroscience Network
Torrance, California, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Accurate Clinical Trials
Kissimmee, Florida, United States
Galiz Research
Miami Springs, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive NeuroScience Inc.
Atlanta, Georgia, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
Lousiana Clinical Research, LLC
Shreveport, Louisiana, United States
Center for Behavioral Health, LLC
Rockville, Maryland, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Psych Care Consultants Research
St Louis, Missouri, United States
Robert Lynn Horne, MD
Las Vegas, Nevada, United States
CRI Worldwide LLC
Willingboro, New Jersey, United States
Erie County Medical Center, Corp
Buffalo, New York, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, United States
Comprehensive Clinical Development, Inc
Fresh Meadows, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Oklahoma Clinical Research
Oklahoma City, Oklahoma, United States
CRI Worldwide LLC at Kirkbride
Philadelphia, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Community Clinical Research, Inc.
Austin, Texas, United States
FutureSearch Clinical Trials LP
Austin, Texas, United States
FutureSearch Clinical Trials, LP
Dallas, Texas, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
Department of Psychiatry, University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)
Dole, , France
Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)
Toulon, , France
Dipartimento Salute Mentale ASL 1
Massa, , Italy
A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4
Pisa, , Italy
Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'
Lipetsk, , Russia
Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'
Rostov-on-Don, , Russia
St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"
Saint Peterburg, , Russia
St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")
Saint Petersburg, , 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
Military Medical Academy, Clnic for Psychiatry
Belgrade, , Serbia
Institute of Mental Health
Dusica, , Serbia
Clinical Centre Kragujevac, Clinic for psychiatry
Kragujevac, , Serbia
Clinical Centre Nis, Clinic for mental health protection
Niš, , Serbia
Specialized hospital for psychiatric diseases "Sveti Vracevi"
Novi Kneževac, , Serbia
Clinical Centre Vojvodine, Clinic for Psychiatry
Novi Sad, , Serbia
Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie
Bojnice, , Slovakia
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, , Slovakia
Psychiatricka nemocnica Michalovce n.o.
Michalovce, , Slovakia
PsychoLine s.r.o. Psychiatricka ambulancia
Rimavská Sobota, , Slovakia
Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie
Rožňava, , Slovakia
"Centrum zdravia R.B.K., spol. s.r.o.
Svidník, , Slovakia
Cape Trial Centre
Tygervalley, Western Cape, South Africa
Research Unit, Department of Psychiatry Free State Psychiatric Complex
Bloemfontein, , South Africa
Denmar Hospital Consulting Rooms
Pretoria, , South Africa
Countries
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Other Identifiers
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2011-004790-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1050307
Identifier Type: -
Identifier Source: org_study_id
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