NCT00044044

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone 20 mg	Lurasidone 20mg/day tablets
DRUG	Lurasidone 40mg	Lurasidone 40mg/day tablets
DRUG	Lurasidone 80 mg	Lurasidone 80mg/day - 2 40mg tablets
DRUG	Haloperidol 10mg	Haloperidol 10mg/day tablets
DRUG	Placebo	Matching Placebo to Lurasdione and Haloperidol

Timeline

• Start date: 2002-07-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2002-08-20
• Last updated: 2014-04-17
• Results posted: 2011-04-12

Locations

34 sites across 1 country: United States