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 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.
Change in Total PANSS Score From Baseline to the End of the Double Blind Phase [ Time Frame: 6 weeks ]
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Secondary Outcome Measures
CGI-S From Baseline to the End of the Double-blind Treatment [ Time Frame: 6 weeks ]
Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.