Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

Lurasidone HCl is a compound 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.

Key facts

Study ID

NCT00615433

Run by

Sumitomo Pharma America, Inc.

People needed

478

Starts

2008-01-01

Expected to finish

2010-01-01

Last updated by the study team

2015-06-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• K&S Professional Research Services LLC — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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