NCT00088634

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

A Double-blind Fixed-dose Study of Lurasidone (SM-13496) and Placebo in the Treatment of Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Detailed description

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lurasidone	80 mg AM dosing once daily
DRUG	Placebo	Matching Placebo to 40mg lurasidone tablets

Timeline

• Start date: 2004-05-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2004-08-02
• Last updated: 2016-04-08
• Results posted: 2011-03-01

Locations

22 sites across 1 country: United States