Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Tracking Information| Start Date ICMJE | October 2007 |
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| Primary Completion Date | |
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Current Primary Outcome Measures ICMJE
(submitted: October 25, 2007) | Change in total PANSS score from baseline to the end of the double blind phase [ Time Frame: 6 weeks ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00549718 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: October 25, 2007) | CGI-S from baseline to the end of the double-blind treatment [ Time Frame: 6 weeks ] |
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| Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive Information| Brief Title ICMJE | Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia |
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| Official Title ICMJE | A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia |
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| Brief Summary | Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo. |
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Randomized, Double-Blind, Parallel Assignment |
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| Condition ICMJE | Schizophrenia |
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| Intervention ICMJE | Drug: Lurasidone HCl |
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Recruitment Information| Estimated Enrollment ICMJE | 480 |
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| Completion Date | |
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| Primary Completion Date | |
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| Eligibility Criteria ICMJE | Inclusion Criteria: To be eligible to enter the study, each patient must comply with the following inclusion criteria: - Provide written informed consent and aged between 18 and 75 years of age.
- 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: - Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- 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.
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| Gender | Both |
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| Ages | 18 Years to 75 Years |
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| Accepts Healthy Volunteers | |
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| Contacts ICMJE | |
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| Location Countries ICMJE | United States, France, India, Malaysia, Romania, Russian Federation, Ukraine |
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Administrative Information| NCT ID ICMJE | NCT00549718 |
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| Responsible Party | |
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| Study ID Numbers ICMJE | D1050229 |
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| Study Sponsor ICMJE | Dainippon Sumitomo Pharma America |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Principal Investigator: | Gary Booker, MD | Unaffiliated | | | Principal Investigator: | Miranda Chakos, MD | State University of New York - Downstate Medical Center | | | Principal Investigator: | Andrew Cutler, MD | Florida Clinical Research Center, LLC | | | Principal Investigator: | Steven Dubovsky | Erie County Medical Center | | | Principal Investigator: | Carlos Figueroa | Pasadena Research Institute | | | Principal Investigator: | David Flaherty | Segal Institute for Clinical Research | | | Principal Investigator: | Donald Garcia | Future Search Trials of Neurology | | | Principal Investigator: | Lev Gertsik | California Clincal Trials | | | Principal Investigator: | Antony Joseph | International Clinical Research Associates, LLC | | | Principal Investigator: | Gregory Kaczenski | K&S Professional Research Services, LLC | | | Principal Investigator: | Mark Lerman | Alexian Brothers Health System | | | Principal Investigator: | Adam Lowy | Comprehensive NeuroScience, Inc. | | | Principal Investigator: | Raymond Manning | CNRI-Los Angles, LLC | | | Principal Investigator: | Morteza Marandi | Comprehensive NeuroScience, Inc, Cerritos | | | Principal Investigator: | Mark Novitsky | CRI Worldwide, LLC @ Kirkbride Center | | | Principal Investigator: | Michael Plopper | Sharp Mesa Vista Hospital | | | Principal Investigator: | Robert Riesenberg | Atlanta Center for Medical Research | | | Principal Investigator: | Kenneth Sokolski | Clinical Innovations | | | Principal Investigator: | Roger Vogelfanger | Research Stategies, Inc | | | Principal Investigator: | David Walling | Collaborative Neuroscience Network Inc | | | Principal Investigator: | Kashinath Yadalam | Lake Charles Clinical Trials | | | Principal Investigator: | Robert Litman | Center for Behavioral Health, LLC | | | Principal Investigator: | Murray Rosenthal | California Clinical Trials | |
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| Information Provided By | Dainippon Sumitomo Pharma America |
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