Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
NCT ID: NCT00789698
Last Updated: 2015-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2008-12-31
2011-07-31
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
DOUBLE
Study Groups
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Lurasidone HC1
Lurasidone HC1
Lurasidone 40-160 mg/day flexibly dosed.
Quetiapine
Quetiapine XR
Quetiapine XR 200-800 mg/day flexibly dosed.
Interventions
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Lurasidone HC1
Lurasidone 40-160 mg/day flexibly dosed.
Quetiapine XR
Quetiapine XR 200-800 mg/day flexibly dosed.
Eligibility Criteria
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Inclusion Criteria
* Suitable for treatment in an outpatient setting.
Exclusion Criteria
* Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
18 Years
75 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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Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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K&S Professional Research Services, LLC
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc
Cerritos, California, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Synergy Escondido,710 East Grand Ave.
Escondido, California, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, United States
Apostle Clinical Trials, Inc.
Long Beach, California, United States
California Clinical Trials
Paramount, California, United States
Pasadena Research Institute
Pasadena, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States
CNRI- LOs Angeles, LLC
Pico Rivera, California, United States
Clinical Innovations, Inc.
Riverside, California, United States
CNRI - San Diego
San Diego, California, United States
UCSD Medical Drive
Sandeigo, California, United States
Segal Institute for Clinical Research
Highlands Ranch, Colorado, United States
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, United States
Florida Clinical Research Center LLC
Bradenton, Florida, United States
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
Lake Charles, Louisiana, United States
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
St. Louis Research, Inc.
St Louis, Missouri, United States
CRI Worldwide
Willingboro, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Comprehensive Neuroscience, Inc
Holliswood, New York, United States
Community Clinical Research
Austin, Texas, United States
FutureSearch Clinical Trials, LLC.
Austin, Texas, United States
Pillar Clinical Research
Dallas, Texas, United States
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Calle 80#47-43 Consultorio 5C, Barranquila S/N, Colombia
Centro de Investigacion y Atencion para la Salud Mental
Calle 103A # 21-49, Bogota S/N, Colombia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, , Colombia
Centro de Investigación y Atención para la Salud Mental
Bogotá, , Colombia
CISNE - UIC Campo Abierto
Bogotá, , Colombia
Instituto Colombiano del Sistema Nervioso Clínica Montserrat
Bogotá, , Colombia
S.V. Medical College
Tirupati, Andhra Pradesh, India
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, India
Shanti Nursing Home
Kanchanpalli, Aurangabad, Maharashtra, India
Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, India
SBKS Medical College and Hospital, Brij Psychiatry Hospital
Vadodara, Gujarat, India
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, India
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
Mahatma Gandhi Institute of Medical Sciences
Sewāgrām, Maharashtra, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, India
Spitalul Clinic Judetean de Urgenta Arad
Str. Octavian Goga Nr. 17, Arad, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Sos. Berceni Nr. 10-12, București, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest, , Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea, , Romania
Spitalul Judetean Arges
Piteşti, , Romania
Andreev, Boris
Gatchina, , Russia
Gurovich, Isaak
Moscow, , Russia
Morozova, Margarita
Moscow, , Russia
City Psychoneurological Dispensary #7 (with Hospital)
Saint Petersburg, , Russia
City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, , Russia
City Psychiatric Hospital #4
Saint Petersburg, , Russia
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg, , Russia
Neznanov, Nikolay
Saint Petersburg, , Russia
Sheifer, Mikhail
Samara, , Russia
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, , Ukraine
Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
Donetsk, , Ukraine
Kyiv City Clin. Psychoneurolog. Hosp.#1
Kyiv, , Ukraine
Kyiv City Psychoneurological Hospital
Kyviv, , Ukraine
Lviv Reg.St.Cl.Psych.Hosp
Lviv, , Ukraine
Reg. Psychiatric Hospital
Odesa, , Ukraine
Crimean republican Clinical Psychiatric Hospital
Simferopol, , Ukraine
Kherson Regional Psychiatric Hospital
Vil. Stepanovka, Kherson, , Ukraine
Countries
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References
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Loebel A, Cucchiaro J, Xu J, Sarma K, Pikalov A, Kane JM. Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: a 12-month, double-blind, noninferiority study. Schizophr Res. 2013 Jun;147(1):95-102. doi: 10.1016/j.schres.2013.03.013. Epub 2013 Apr 11.
Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.
Other Identifiers
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D1050234
Identifier Type: -
Identifier Source: org_study_id
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