A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
NCT ID: NCT01143077
Last Updated: 2013-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2010-06-30
2011-05-31
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
NONE
Study Groups
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Lurasidone Open-Label Arm A
Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Lurasidone Open-Label Arm B
Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Lurasidone Open-Label Arm C
Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Interventions
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Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
* Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.
Exclusion Criteria
* Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
* Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
18 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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Lurasidone Medical Director, MD
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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K and S Professional Research Services
Little Rock, Arkansas, United States
Synergy Clinical Research of Escondido
Escondido, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
California Clinical Trials
Paramount, California, United States
Pasadena Research Institute
Pasadena, California, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
Pico Rivera, California, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Collaborative Neuroscience Network, South Bay
Torrance, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, United States
Saint Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
The Zucker Hillside Hospital
Glen Oaks, New York, United States
Duke University Dept. of Psychiatry
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, LP
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Wharton Research Center
Houston, Texas, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Countries
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References
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McEvoy JP, Citrome L, Hernandez D, Cucchiaro J, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study. J Clin Psychiatry. 2013 Feb;74(2):170-9. doi: 10.4088/JCP.12m07992.
Awad G, Hassan M, Loebel A, Hsu J, Pikalov A, Rajagopalan K. Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia. BMC Psychiatry. 2014 Feb 23;14:53. doi: 10.1186/1471-244X-14-53.
Other Identifiers
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D1050289
Identifier Type: -
Identifier Source: org_study_id
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