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

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

Secondary Outcome Measures

Name	Time	Method

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
Fidelity Clinical Research Inc.
🇺🇸
North Miami, Florida, United States
Croatian institute for brain research Neuron
🇭🇷
Zagreb, Croatia
Comprehensive NeuroScience, Inc.
🇺🇸
Washington, District of Columbia, United States
Beer Ya'acov Mental Health Center
🇮🇱
Beer Yaakov, Israel
Shalvata Mental Health Center, Ward B
🇮🇱
Hod Hasharon, Israel
Comprehensive NeuroScience, Inc. - Cerritos
🇺🇸
Cerritos, California, United States
Collaborative Neuroscience Network Inc
🇺🇸
Torrance, California, United States
South Coast Clinical Trials, Inc.
🇺🇸
Anaheim, California, United States
Shalvata Mental Health Center
🇮🇱
Hod Hasharon, Israel
Sheppard Pratt Health System
🇺🇸
Baltimore, Maryland, United States
Hospital Base Valdivia
🇨🇱
Valdivia, Chile
Clinical Hospital Centre Rijeka
🇭🇷
Rijeka, Croatia
Psychiatric Hospital Vrapce
🇭🇷
Zagreb, Croatia
Northlake Medical Research Center
🇺🇸
Tucker, Georgia, United States
Somdet Chaopraya Institute of Psychiatry
🇹🇭
Klongsan, Bangkok, Thailand
Hospital Clincio Felix Bulnes
🇨🇱
Quinta Normal, Santiago, Chile
CIPAM - Clínica Pedro Montt
🇨🇱
Santiago, Chile
Chaim Sheba Medical Center
🇮🇱
Ramat Gan, Israel
Hospital Espirita de Psiquiatria Bom Retiro
🇧🇷
Curitiba, PR, Brazil
Flexivest fourteen Research Centre
🇿🇦
Cape Town, W Cape, South Africa
Rambam Health Care Campus
🇮🇱
Haifa, Israel
Oranje Hospital
🇿🇦
Bloemfontein, Free State, South Africa
Private Practice
🇿🇦
Pretoria, Gauteng, South Africa
Suan Prung Psychiatric Hospital
🇹🇭
Muang, Chiang Mai, Thailand
Cape Trial Centre
🇿🇦
Cape Town, South Africa
Rand Clinic
🇿🇦
Johannesburg, Gauteng, South Africa
Crompton Medical Centre East
🇿🇦
Natal, South Africa
Clinical Innovations Inc.
🇺🇸
Santa Ana, California, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
CNRI-San Diego LLC
🇺🇸
San Diego, California, United States
UCSD, Outpatient Psychiatric Services
🇺🇸
San Diego, California, United States
King Chulalongkorn Memorial Hospital
🇹🇭
Chulalongkorn University, Bangkok, Thailand
Hospital Barros Luco Trudeau
🇨🇱
San Miguel, Santiago, Chile
Creighton University
🇺🇸
Omaha, Nebraska, United States
Weskoppies Hospital
🇿🇦
Pretoria West, South Africa
Excell Research
🇺🇸
Oceanside, California, United States
CNRI-Los Angeles, LLC
🇺🇸
Pico Rivera, California, United States
University of California at Irvine Medical Center
🇺🇸
Orange, California, United States
Pasadena Research Institute
🇺🇸
Pasadena, California, United States
Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
🇺🇸
North Miami, Florida, United States
Alexian Brothers Medical Center
🇺🇸
Hoffman Estates, Illinois, United States
Lake Charles Clinical Trials
🇺🇸
Lake Charles, Louisiana, United States
Precise Research Center
🇺🇸
Flowood, Mississippi, United States
St. Louis Clinical Trials
🇺🇸
St. Louis, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research
🇺🇸
St. Charles, Missouri, United States
SUNY Downstate University
🇺🇸
Brooklyn, New York, United States
Neurobehavioral Research Inc.
🇺🇸
Cedarhurst, New York, United States
CRI Worldwide
🇺🇸
Philadelphia, Pennsylvania, United States
Manhattan Psychiatric Center
🇺🇸
New York, New York, United States
Social Psychiatry Research Institute
🇺🇸
New York, New York, United States
Research Strategies of Memphis LLC
🇺🇸
Memphis, Tennessee, United States
University of North Carolina at Chapel Hill
🇺🇸
Raleigh, North Carolina, United States
Keystone Clinical Studies, LLC
🇺🇸
Norristown, Pennsylvania, United States
Community Clinical Research, Inc.
🇺🇸
Austin, Texas, United States
Claghorn-Lesem Research Clinic, Inc.
🇺🇸
Houston, Texas, United States
Pillar Clinical Research LLC
🇺🇸
Dallas, Texas, United States
CIAP
🇦🇷
Rosario, SFE, Argentina
Resolution Psychopharmacology Research Institute
🇦🇷
Mendoza, MEN, Argentina
Alliance Research Group
🇺🇸
Richmond, Virginia, United States
Fundación para el Estudio y Tratamiento de las Enf. Mentales
🇦🇷
Capital Federal, BUE, Argentina
Clinica Privada Neuropsiquiatrica San Agustin
🇦🇷
La Plata, BUE, Argentina
Sanatorio Sao Paulo
🇧🇷
Salvador, BA, Brazil
Sanatorio 'Prof. Leon S. Morra' S.A.
🇦🇷
Cordoba, Argentina
Hospital Mario Kroeff
🇧🇷
Rio de Janeiro, RJ, Brazil
PAX Clinica Psiquiatrica Ltda
🇧🇷
Aparecida de Goiania, Brazil
Instituto Psiquiátrico Dr. José Horwitz Barak
🇨🇱
Recoleta, Santiago, Chile