NCT01821378

Lurasidone Low-Dose - High-Dose Study Study

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Low-dose Lurasidone in Acutely Psychotic Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.

Detailed description

The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia. This study will also evaluate the efficacy and safety of lurasidone 80 mg/day and160 mg/day versus placebo in subjects who are early non-responders (operationally defined per protocol) to lurasidone 80 mg/day.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone	Lurasidone 20 mg once daily
DRUG	Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2	Lurasidone 80 mg once daily
DRUG	Placebo	Once Daily

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-04-01
• Last updated: 2016-07-21
• Results posted: 2016-01-08

Locations

66 sites across 6 countries: United States, Colombia, Romania, Russia, Slovakia, Ukraine