Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
NCT ID: NCT00641745
Last Updated: 2015-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2008-03-31
2010-07-31
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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1
Lurasidone
Lurasidone HCl
40 - 120mg per day
2
Risperidone
Risperidone
Risperidone
Interventions
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Lurasidone HCl
40 - 120mg per day
Risperidone
Risperidone
Eligibility Criteria
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Inclusion Criteria
* Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
* Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
* Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
* Subject voluntarily agrees to participate in the study by giving written informed consent.
Exclusion Criteria
* Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
* Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
* In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
* Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
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, LLC
Little Rock, Arkansas, United States
South Coast Clinical Trials, Inc.
Anaheim, California, United States
Comprehensive NeuroScience, Inc. - Cerritos
Cerritos, California, United States
Clinical Innovations Inc.
Costa Mesa, California, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, United States
University of Southern California
Los Angeles, California, United States
Excell Research
Oceanside, California, United States
University of California at Irvine Medical Center
Orange, California, United States
Pasadena Research Institute
Pasadena, California, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, United States
Clinical Innovations Inc.
Riverside, California, United States
CNRI-San Diego LLC
San Diego, California, United States
UCSD, Outpatient Psychiatric Services
San Diego, California, United States
Clinical Innovations Inc.
Santa Ana, California, United States
Collaborative Neuroscience Network Inc
Torrance, California, United States
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, United States
Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
North Miami, Florida, United States
Fidelity Clinical Research Inc.
North Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Northlake Medical Research Center
Tucker, Georgia, United States
Alexian Brothers Medical Center
Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
Precise Research Center
Flowood, Mississippi, United States
St. Charles Psychiatric Associates - Midwest Research
Saint Charles, Missouri, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Creighton University
Omaha, Nebraska, United States
CRI Worldwide
Willingboro, New Jersey, United States
SUNY Downstate University
Brooklyn, New York, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, United States
Manhattan Psychiatric Center
New York, New York, United States
Social Psychiatry Research Institute
New York, New York, United States
University of North Carolina at Chapel Hill
Raleigh, North Carolina, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Research Strategies of Memphis LLC
Memphis, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Pillar Clinical Research LLC
Dallas, Texas, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, United States
Alliance Research Group
Richmond, Virginia, United States
Fundación para el Estudio y Tratamiento de las Enf. Mentales
Capital Federal, BUE, Argentina
Clinica Privada Neuropsiquiatrica San Agustin
La Plata, BUE, Argentina
Resolution Psychopharmacology Research Institute
Mendoza, MEN, Argentina
CIAP
Rosario, SFE, Argentina
Sanatorio 'Prof. Leon S. Morra' S.A.
Córdoba, , Argentina
Sanatorio Sao Paulo
Salvador, Estado de Bahia, Brazil
Hospital Espirita de Psiquiatria Bom Retiro
Curitiba, Paraná, Brazil
Hospital Mario Kroeff
Rio de Janeiro, Rio de Janeiro, Brazil
PAX Clinica Psiquiatrica Ltda
Aparecida de Goiânia, , Brazil
Hospital Clincio Felix Bulnes
Quinta Normal, Santiago Metropolitan, Chile
Instituto Psiquiátrico Dr. José Horwitz Barak
Recoleta, Santiago Metropolitan, Chile
Hospital Barros Luco Trudeau
San Miguel, Santiago Metropolitan, Chile
CIPAM - Clínica Pedro Montt
Santiago, Santiago Metropolitan, Chile
Hospital Base Valdivia
Valdivia, Valdivia, Chile
Psychiatric Hospital Vrapce
Zagreb, City of Zagreb, Croatia
Croatian institute for brain research Neuron
Zagreb, City of Zagreb, Croatia
Clinical Hospital Centre Rijeka
Rijeka, Rijeka, Croatia
Beer Ya'acov Mental Health Center
Beer Yaakov, Beer Yaakov, Israel
Rambam Health Care Campus
Haifa, Haifa District, Israel
Shalvata Mental Health Center
Hod HaSharon, Hod Hasharon, Israel
Chaim Sheba Medical Center
Ramat Gan, Ramat Gan, Israel
Shalvata Mental Health Center, Ward B
Hod HaSharon, , Israel
Oranje Hospital
Bloemfontein, Free State, South Africa
Rand Clinic
Johannesburg, Gauteng, South Africa
Private Practice
Pretoria, Gauteng, South Africa
Flexivest fourteen Research Centre
Cape Town, W Cape, South Africa
Cape Trial Centre
Cape Town, , South Africa
Crompton Medical Centre East
Natal, , South Africa
Weskoppies Hospital
Pretoria West, , South Africa
King Chulalongkorn Memorial Hospital
Chulalongkorn University, Bangkok, Thailand
Somdet Chaopraya Institute of Psychiatry
Klongsan, Bangkok, Thailand
Suan Prung Psychiatric Hospital
Muang, Chiang Mai, Thailand
Countries
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References
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Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31.
Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/YIC.0b013e32835281ef.
Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.
Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Other Identifiers
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D1050237
Identifier Type: -
Identifier Source: org_study_id
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