A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 489
- Locations
- 48
- Primary Endpoint
- Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Lurasidone 40mg
Intervention: Lurasidone HCl (Drug)
Lurasidone 80mg
Intervention: Lurasidone HCl (Drug)
Lurasidone 120mg
Intervention: Lurasidone HCl (Drug)
Sugar Pill
Intervention: Lurasidone HCl (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- CGI-S From Baseline to the End of the Double-blind Treatment(6 weeks)