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)
K&S Professional Research Services LLC
🇺🇸Little Rock, Arkansas, United States
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
Scroll for more (42 remaining)K&S Professional Research Services LLC🇺🇸Little Rock, Arkansas, United States