Safety and Tolerability Study of Drug to Treat Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Lurasidone 80mg; Drug: Lurasidone 20 mg; Drug: Lurasidone 40 mg

• Registration Number: NCT00044005
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-08-16
• Study First Submitted QC: 2002-08-19
• Study First Posted: 2002-08-20
• Study Start: 2002-09
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Results First Submitted: 2011-02-16
• Results First Submitted QC: 2011-04-19
• Results First Posted: 2011-05-19
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lurasidone 80mg	Lurasidone 80mg	Lurasidone 80mg oral tablet
Lurasidone 20 mg	Lurasidone 20 mg	Lurasidone 20 mg oral tablet
Lurasidione 40 mg	Lurasidone 40 mg	Lurasidone 40 mg oral tablet

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	6-months	The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.

Trial Locations

Locations (26)

University of California, Irvine; 🇺🇸 Orange, California, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Lake Mead Hospital; 🇺🇸 North Las Vegas, Nevada, United States

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

FutureSearch Trials; 🇺🇸 Austin, Texas, United States

CNS Network; 🇺🇸 Garden Grove, California, United States

Psychiatric Institute of Washington; 🇺🇸 Washington, District of Columbia, United States

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Comprehensive Neuroscience. Inc.; 🇺🇸 Melbourne, Florida, United States

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

ClinSearch, Inc.; 🇺🇸 Kenilworth, New Jersey, United States

Institute for Psychopharmacology Research; 🇺🇸 Cerritos, California, United States

Hawaii Research Center; 🇺🇸 Honolulu, Hawaii, United States

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Coordinated Research of Florida, Inc; 🇺🇸 Winter Park, Florida, United States

St. Paul Medical Center; 🇺🇸 Dallas, Texas, United States

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

CNS, Inc.; 🇺🇸 Falls Church, Virginia, United States

California Neuropsychopharmacology Clinical Research Institute; 🇺🇸 San Diego, California, United States

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

Comprehensive Clinical Research, CNS; 🇺🇸 Clementon, New Jersey, United States

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

Medstream, Inc.; 🇺🇸 Milwaukee, Wisconsin, United States

Alexian Brothers Behavioral Health Hospital; 🇺🇸 Hoffman Estates, Illinois, United States

American Medical Research; 🇺🇸 Oakbrook, Illinois, United States

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