Skip to main content
Clinical Trials/NCT00549718
NCT00549718CompletedPhase 3

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

Sumitomo Pharma America, Inc.48 sites in 7 countries489 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs

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

Experimental

Intervention: Lurasidone HCl (Drug)

Lurasidone 80mg

Experimental

Intervention: Lurasidone HCl (Drug)

Lurasidone 120mg

Experimental

Intervention: Lurasidone HCl (Drug)

Sugar Pill

Placebo Comparator

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (48)

Loading locations...

Similar Trials