A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
NCT ID: NCT00088634
Last Updated: 2016-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2004-05-31
2004-12-31
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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Lurasidone
80 mg AM dosing once daily
Lurasidone
80 mg AM dosing once daily
Placebo
Placebo
Matching Placebo to 40mg lurasidone tablets
Interventions
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Lurasidone
80 mg AM dosing once daily
Placebo
Matching Placebo to 40mg lurasidone tablets
Eligibility Criteria
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Inclusion Criteria
* The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
* If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception
Exclusion Criteria
* The patient has participated in a previous study of this compound
18 Years
64 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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Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, United States
Summit Research Group
Little Rock, Arkansas, United States
Comprehensive NeuroScience
Cerritos, California, United States
Collaborative Neuro Science Network, Inc.
Garden Grove, California, United States
Optimum Health Services
La Mesa, California, United States
California Clinical Trials
San Diego, California, United States
CNRI, LLC San Diego
San Diego, California, United States
Pacific Clinical Research
Upland, California, United States
Comprehensive NeuroScience, Inc
Washington D.C., District of Columbia, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
The Segal Institute
North Miami, Florida, United States
University of South Florida, Department of Psychiatry and Behavioral Medicine
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, United States
Robert Lynn Horne, MD, Suite 4
Las Vegas, Nevada, United States
CNS Research Institute
Clementon, New Jersey, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, United States
Community Clinical Research
Austin, Texas, United States
Future Search Trials
Austin, Texas, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
CBH Health, L.L.C - Dominion Hospital
Falls Church, Virginia, United States
Countries
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References
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Nakamura M, Ogasa M, Guarino J, Phillips D, Severs J, Cucchiaro J, Loebel A. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 Jun;70(6):829-36. doi: 10.4088/JCP.08m04905. Epub 2009 Jun 2.
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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D1050196
Identifier Type: -
Identifier Source: org_study_id
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