A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
NCT ID: NCT00044044
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
356 participants
INTERVENTIONAL
2002-07-31
2003-05-31
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 20 mg
Lurasidone 20 mg tablets
Lurasidone 20 mg
Lurasidone 20mg/day tablets
Lurasidone 40 mg
Lurasidone 40 mg tablets
Lurasidone 40mg
Lurasidone 40mg/day tablets
Lurasidone 80 mg
Lurasidone 2 40 mg tablets
Lurasidone 80 mg
Lurasidone 80mg/day - 2 40mg tablets
Haloperidol 10mg
Haloperidol 10mg tablets
Haloperidol 10mg
Haloperidol 10mg/day tablets
Placebo
Matching Placebo to Lurasidone and Haloperidol
Placebo
Matching Placebo to Lurasdione and Haloperidol
Interventions
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Lurasidone 20 mg
Lurasidone 20mg/day tablets
Lurasidone 40mg
Lurasidone 40mg/day tablets
Lurasidone 80 mg
Lurasidone 80mg/day - 2 40mg tablets
Haloperidol 10mg
Haloperidol 10mg/day tablets
Placebo
Matching Placebo to Lurasdione and Haloperidol
Eligibility Criteria
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Inclusion Criteria
* The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
* The patient has had a duration of illness of at least one year.
* The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
* The patient is able to remain off antipsychotic medication for a 4 day washout period
Exclusion Criteria
* The patient is considered treatment resistant-Substance abuse-Prolactin level of \> 200 ng/mL at baseline
* Pregnancy
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
Institute for Psychopharmacology Research
Cerritos, California, United States
CNS Network
Garden Grove, California, United States
California Clinical Trials Medical Group
Glendale, California, United States
Optimum Health Services
La Mesa, California, United States
University of California, Irvine
Orange, California, United States
Affiliated Research Institute
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, United States
Comprehensive Neuroscience. Inc.
Washington D.C., District of Columbia, United States
Comprehensive Neuroscience. Inc.
Melbourne, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Coordinated Research of Florida, Inc.
Winter Park, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Hawaii Research Center
Honolulu, Hawaii, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
American Medical Research
Oak Brook, Illinois, United States
Centers for Behavioral Health, LLC
Rockville, Maryland, United States
Lake Mead Hospital
North Las Vegas, Nevada, United States
Comprehensive Clinical Research CNS, PC
Clementon, New Jersey, United States
ClinSearch, Inc.
Kenilworth, New Jersey, United States
Psychiatric Professional Services Inc
Cincinnati, Ohio, United States
Quantum Clinical Services Group
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center - Dept. of Psychiatry
Philadelphia, Pennsylvania, United States
Community Clinical Research
Austin, Texas, United States
FutureSearch Trials
Austin, Texas, United States
Claghorn Lesem Research Clinic, Inc.
Bellaire, Texas, United States
St. Paul Medical Center
Dallas, Texas, United States
University Hills Clinical Research
Dallas, Texas, United States
CNS, Inc.
Falls Church, Virginia, United States
Northwest Clinical Research Center
Belleview, Washington, United States
Medstream, Inc.
Milwaukee, Wisconsin, United States
Countries
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References
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Storman D, Koperny M, Styczen K, Datka W, Jaeschke RR. Lurasidone versus typical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2025 Jan 20;1(1):CD012429. doi: 10.1002/14651858.CD012429.pub2.
Other Identifiers
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D1050049
Identifier Type: -
Identifier Source: org_study_id
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