Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Completed · Phase 3
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT00549718
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 489
- Starts
- 2007-10-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2014-06-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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
- K&S Professional Research Services, LLC. — Little Rock, Arkansas, United States
- Comprehensive Neuroscience, Inc — Cerritos, California, United States
- Clinical Innovations, Inc. — Costa Mesa, California, United States
- Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3 — Garden Grove, California, United States
- California Clinical Trials — Paramount, California, United States
- Pasadena Research Institute — Pasadena, California, United States
- California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road — Pico Rivera, California, United States
- Sharp Mesa Vista Hospital — San Diego, California, United States
- Comprehensive Neuroscience, Inc. — Washington D.C., District of Columbia, United States
- Florida Clinical Research Center, LLC — Bradenton, Florida, United States
- Segal Institute for Clinical Research, Fidelity Clinical Research, Inc. — North Miami, Florida, United States
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Alexian Brothers Health System — Hoffman Estates, Illinois, United States
- Lake Charles Clinical Trials LLC — Lake Charles, Louisiana, United States
- Booker, J. Gary, MD. APMC — Shreveport, Louisiana, United States
- Center for Behavioral Health, LLC — Rockville, Maryland, United States
- SUNY Downstate Medical Center — Brooklyn, New York, United States
- Erie County Medical Center, Corp — Buffalo, New York, United States
- CRI Worldwide LLC at Kirkbride — Philadelphia, Pennsylvania, United States
- Research Strategies of Memphis, LLC. — Memphis, Tennessee, United States
- Future Search Trials of Neurology — Austin, Texas, United States
- Hospital Caremeau — Nîmes, France
- S V Medical College — Tirupati, Andh Prad, India
- Government Hospital for Mental Care — Visakhapatnam, Andh Prad, India
- Sheth Vadilal Sarabhai General Hospital — Ahmedabad, Gujarat, India
Full record on ClinicalTrials.gov
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