Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT00615433
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lurasdione 40mg tablets Lurasidone 40 mg tablets - 15mg Olz Olanzapine - Sugar pill Placebo comparator - 120mg Lurasidone -
- Primary Outcome Measures
Name Time Method Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. Baseline and 6 weeks The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
- Secondary Outcome Measures
Name Time Method CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. 6 weeks The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.
Trial Locations
- Locations (52)
Lousiana Clinical Research, LLC
🇺🇸Shreveport, Louisiana, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Clinical Pharmacological Studies, Inc.
🇺🇸Cerritos, California, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
California Clinical Trials
🇺🇸Paramount, California, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
CRI Worldwide @ Lourdes
🇺🇸Willingboro, New Jersey, United States
St. Louis Clinical Trials
🇺🇸St. Louis, Missouri, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
🇨🇴Barranquilla, Colombia
Shanti Nursing Home
🇮🇳Aurangabad, Mahara, India
Siauliai Mental Hospital, Public Institution
🇱🇹Siauliai, Lithuania
Father Muller Institute of Medical Education and Research
🇮🇳Mangalore, Karna, India
Justice K.S. Hedge Charitable Hospital
🇮🇳Mangalore, Karna, India
JSS Medical College and Hospital - Dept of Psychiatry
🇮🇳Mysore, Karna, India
Republican Vilnius Psychiatry Hospital, Public Institution
🇱🇹Vilnius, Lithuania
National Center for Mental Health
🇵ðŸ‡Mandaluyong City, Philippines
Sheth Vadilal Sarabhai General Hospital
🇮🇳Ahmedabad, Gujarat, India
Vijayawada Institute of Mental Health and Neurosciences
🇮🇳Vijaywada, Andh Prad, India
Kasturba Hospital
🇮🇳Manipal, Karna, India
Kasturba Medical College
🇮🇳Mangalore, Karna, India
Deenanath Mangeshkar Hospital
🇮🇳Pune, Mahara, India
Klaipeda Mental Hospital, Public Institution
🇱🇹Klaipeda, Lithuania
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
🇨🇴Cundinamarca, Bogota, Colombia
Davao Medical School Foundation Hospital
🇵ðŸ‡Davao City, Philippines
Makati Medical Center
🇵ðŸ‡Makati City, Philippines
Vanderbilt Heart and Vascular Institute
🇺🇸Nashville, Tennessee, United States
Victoria Hospital
🇮🇳Bangalore, Karna, India
Ziegzdriai Mental Hospital, Public Institution
🇱🇹Kaunas, Lithuania
Metro Psych Facility
🇵ðŸ‡Mandaue City, Philippines
Madras Medical College & Government General Hospital
🇮🇳Chennai, TamilNadu, India
Precise Research Center
🇺🇸Flowood, Mississippi, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Florida Clinical Research Center, LLC
🇺🇸Fruitland Park, Florida, United States
CNRI - San Diego, LLC
🇺🇸San Diego, California, United States
St. Charles Psychiatric Associates-Midwest Research
🇺🇸St. Charles, Missouri, United States
K&S Professional Research Services LLC
🇺🇸Little Rock, Arkansas, United States
Alexian Brothers Health System
🇺🇸Hoffman Estates, Illinois, United States
Collaborative Neuroscience Network Inc.
🇺🇸Torrance, California, United States
Centro de Investigaciones del Sistema Nervioso Limitada
🇨🇴Bogota, Colombia
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Neurobehavioral Research Inc.
🇺🇸Cedarhurst, New York, United States
Claghorn-Lesem Research Clinic, Inc.
🇺🇸Houston, Texas, United States
Government Hospital for Mental Care
🇮🇳Visakhapatnam, Andh Prad, India
Hospital for Mental Health - Dept of Psychiatry
🇮🇳Ahmedabad, Gujarat, India
SBKS Medical College and Brij Psychiatry Hospital
🇮🇳Vadodara, Gujarat, India
Centro de Investigacion y Atencion para la Salud Mental
🇨🇴Bogota, Colombia
Psynapsis Salud Mental, S.A.
🇨🇴Risaralda, Colombia
Excell Research
🇺🇸Oceanside, California, United States
University of North Carolina at Chapel Hill
🇺🇸Raleigh, North Carolina, United States