Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Lurasidone HCl; Drug: Risperidone

• Registration Number: NCT00641745
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-09-01
• Results First Submitted QC: 2011-09-01
• Results First Posted: 2011-10-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

• Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
• Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
• Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
• Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
• Subject voluntarily agrees to participate in the study by giving written informed consent.

Main

Exclusion Criteria

To be excluded from entering this study if they fulfil any of the criteria below:

• Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
• Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
• In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
• Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lurasidone HCl	Lurasidone
2	Risperidone	Risperidone

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events.	12 months

Trial Locations

Locations (69)

K&S Professional Research Services LLC; 🇺🇸 Little Rock, Arkansas, United States

Woodland International Research Group, LLC; 🇺🇸 Little Rock, Arkansas, United States

South Coast Clinical Trials, Inc.; 🇺🇸 Anaheim, California, United States

Comprehensive NeuroScience, Inc. - Cerritos; 🇺🇸 Cerritos, California, United States

Clinical Innovations Inc.; 🇺🇸 Santa Ana, California, United States

Collaborative Neuroscience Network Inc; 🇺🇸 Torrance, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

University of California at Irvine Medical Center; 🇺🇸 Orange, California, United States

Pasadena Research Institute; 🇺🇸 Pasadena, California, United States

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