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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lurasidone 80mg tablet

• Registration Number: NCT00088621
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-07-30
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Results First Submitted: 2011-02-11
• Results First Submitted QC: 2011-04-11
• Results First Posted: 2011-05-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lurasidone 80 mg tablet	Lurasidone 80mg tablet	Lurasidone 80mg oral tablet taken once a day

Primary Outcome Measures

Name	Time	Method
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study	1 year

Trial Locations

Locations (19)

Segal Institute for Clinical Research; 🇺🇸 North Miami, Florida, United States

Optimum Health Services; 🇺🇸 La Mesa, California, United States

Birmingham Psychiatry Pharmaceutical; 🇺🇸 Birmingham, Alabama, United States

Collaborative Neuro Science Network, Inc.; 🇺🇸 Garden Grove, California, United States

Summit Research Group; 🇺🇸 Little Rock, Arkansas, United States

California Clinical Trials; 🇺🇸 San Diego, California, United States

CA Neutopsychopharmacology Clinical Research Institute (CNRI); 🇺🇸 San Diego, California, United States

Comprehensive NeuroScience, Inc; 🇺🇸 Washington, District of Columbia, United States

CNS Research Institute; 🇺🇸 Clementon, New Jersey, United States

Comprehensive NeuroScience; 🇺🇸 Cerritos, California, United States

Pacific Clinical Research; 🇺🇸 Upland, California, United States

Quantum Clinical Services Group; 🇺🇸 Philadelphia, Pennsylvania, United States

University of South Florida, Department of Psychiatry and Behavioral Medicine; 🇺🇸 Tampa, Florida, United States

Community Clinical Research; 🇺🇸 Austin, Texas, United States

InSite Clinical Research; 🇺🇸 DeSoto, Texas, United States

Future Search Trials; 🇺🇸 Austin, Texas, United States

Claghorn Lesem Research Clinic, Inc.; 🇺🇸 Bellaire, Texas, United States

Comprehensive Neuroscience, Inc.; 🇺🇸 Hoffman Estates, Illinois, United States

CBH Health, L.L.C - Dominion Hospital; 🇺🇸 Falls Church, Virginia, United States