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

Schizophrenia Clinical Trial

Official title:

Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641745
• Other study ID #: D1050237
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2008
• Last updated: June 16, 2015
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: June 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilChile: Instituto de Salud Pública de ChileThailand: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of HealthCroatia: Ministry of Health and Social CareIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Main 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Lurasidone HCl
40 - 120mg per day
• Risperidone
Risperidone

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Croatia,  Israel,  South Africa,  Thailand, 

References & Publications (2)

Citrome L, Cucchiaro J, Sarma K, Phillips D, Silva R, Tsuchiya S, Loebel A. Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 10.1097/ — View Citation

Keefe RS, Fox KH, Harvey PD, Cucchiaro J, Siu C, Loebel A. Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial. Schizophr Res. 2011 Feb;125(2-3):161-8. doi: 10.1016/j.schres.2010.09.015. Epub 2010 Dec 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events.		12 months	Yes