Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. [ Time Frame: 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
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. [ Time Frame: 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.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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