NCT00088621

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Detailed description

Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale \[AIMS\], Barnes Akathisia Scale \[BAS\], and Simpson-Angus Rating Scale \[SAS\]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone 80mg tablet

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2004-08-02
• Last updated: 2014-04-17
• Results posted: 2011-05-06

Locations

21 sites across 1 country: United States