Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
NCT ID: NCT00615433
Last Updated: 2015-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
478 participants
INTERVENTIONAL
2008-01-31
2010-01-31
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
TRIPLE
Study Groups
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Lurasdione 40mg tablets
Lurasidone 40 mg tablets
Lurasidone 40 mg tablets
120mg
Lurasidone
120mg/day
15mg Olz
Olanzapine
15mg/day
Sugar pill
Placebo comparator
Placebor Comparator
Interventions
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Lurasidone
120mg/day
Olanzapine
15mg/day
Placebo comparator
Placebor Comparator
Lurasidone 40 mg tablets
Lurasidone 40 mg tablets
Eligibility Criteria
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Inclusion Criteria
* Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Good physical health on the basis of medical history, physical examination, and laboratory screening.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
Exclusion Criteria
* Any chronic organic disease of the CNS (other than schizophrenia).
* Used investigational compound within 30 days.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
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
Clinical Pharmacological Studies, Inc.
Cerritos, California, United States
Excell Research
Oceanside, California, United States
University of California at Irvine Medical Center
Orange, California, United States
California Clinical Trials
Paramount, California, United States
CNRI - San Diego, LLC
San Diego, California, United States
UCSD Medical Center
San Diego, California, United States
Collaborative Neuroscience Network Inc.
Torrance, California, United States
Florida Clinical Research Center, LLC
Fruitland Park, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Alexian Brothers Health System
Hoffman Estates, Illinois, United States
Lousiana Clinical Research, LLC
Shreveport, Louisiana, 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
CRI Worldwide @ Lourdes
Willingboro, New Jersey, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, United States
University of North Carolina at Chapel Hill
Raleigh, North Carolina, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, United States
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
Cundinamarca, Bogota D.C., Colombia
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Barranquilla, , Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogotá, , Colombia
Centro de Investigaciones del Sistema Nervioso Limitada
Bogotá, , Colombia
Psynapsis Salud Mental, S.A.
Risaralda, , Colombia
Vijayawada Institute of Mental Health and Neurosciences
Vijaywada, Andh Prad, India
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, India
Hospital for Mental Health - Dept of Psychiatry
Ahmedabad, Gujarat, India
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, India
SBKS Medical College and Brij Psychiatry Hospital
Vadodara, Gujarat, India
Victoria Hospital
Bangalore, Karna, India
Kasturba Medical College
Mangalore, Karna, India
Father Muller Institute of Medical Education and Research
Mangalore, Karna, India
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, India
Kasturba Hospital
Manipal, Karna, India
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, India
Shanti Nursing Home
Aurangabad, Mahara, India
Deenanath Mangeshkar Hospital
Pune, Mahara, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, India
Ziegzdriai Mental Hospital, Public Institution
Kaunas, , Lithuania
Klaipeda Mental Hospital, Public Institution
Klaipėda, , Lithuania
Siauliai Mental Hospital, Public Institution
Šiauliai, , Lithuania
Republican Vilnius Psychiatry Hospital, Public Institution
Vilnius, , Lithuania
Davao Medical School Foundation Hospital
Davao City, , Philippines
Makati Medical Center
Makati City, , Philippines
National Center for Mental Health
Mandaluyong, , Philippines
Metro Psych Facility
Mandaue City, , Philippines
Countries
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References
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Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
Stahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.
Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
Other Identifiers
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D1050231
Identifier Type: -
Identifier Source: org_study_id
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