Clinical trial NCT00641745: Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Official title: Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Lurasidone
Schizophrenia
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Professional Research Services LLC
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group, LLC
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials, Inc.
state: California
city: Cerritos
country: United States
facility: Comprehensive NeuroScience, Inc. - Cerritos
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations Inc.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute
state: California
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles, LLC
state: California
city: Riverside
country: United States
facility: Clinical Innovations Inc.
state: California
city: San Diego
country: United States
facility: CNRI-San Diego LLC
state: California
city: San Diego
country: United States
facility: UCSD, Outpatient Psychiatric Services
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network Inc
state: California
city: Washington
country: United States
facility: Comprehensive NeuroScience, Inc.
state: District of Columbia
city: North Miami
country: United States
facility: Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
state: Florida
city: North Miami
country: United States
facility: Fidelity Clinical Research Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Tucker
country: United States
facility: Northlake Medical Research Center
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Flowood
country: United States
facility: Precise Research Center
state: Mississippi
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Willingboro
country: United States
facility: CRI Worldwide
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY Downstate University
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc.
state: New York
city: New York
country: United States
facility: Manhattan Psychiatric Center
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Raleigh
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Norristown
country: United States
facility: Keystone Clinical Studies, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Memphis
country: United States
facility: Research Strategies of Memphis LLC
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research LLC
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Inc.
state: Texas
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Capital Federal
country: Argentina
facility: Fundación para el Estudio y Tratamiento de las Enf. Mentales
state: BUE
city: La Plata
country: Argentina
facility: Clinica Privada Neuropsiquiatrica San Agustin
state: BUE
city: Mendoza
country: Argentina
facility: Resolution Psychopharmacology Research Institute
state: MEN
city: Rosario
country: Argentina
facility: CIAP
state: SFE
city: Cordoba
country: Argentina
facility: Sanatorio 'Prof. Leon S. Morra' S.A.
city: Salvador
country: Brazil
facility: Sanatorio Sao Paulo
state: BA
city: Curitiba
country: Brazil
facility: Hospital Espirita de Psiquiatria Bom Retiro
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Mario Kroeff
state: RJ
city: Aparecida de Goiania
country: Brazil
facility: PAX Clinica Psiquiatrica Ltda
city: Quinta Normal
country: Chile
facility: Hospital Clincio Felix Bulnes
state: Santiago
city: Recoleta
country: Chile
facility: Instituto Psiquiátrico Dr. José Horwitz Barak
state: Santiago
city: San Miguel
country: Chile
facility: Hospital Barros Luco Trudeau
state: Santiago
city: Santiago
country: Chile
facility: CIPAM - Clínica Pedro Montt
city: Valdivia
country: Chile
facility: Hospital Base Valdivia
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Psychiatric Hospital Vrapce
city: Zagreb
country: Croatia
facility: Croatian institute for brain research Neuron
city: Beer Yaakov
country: Israel
facility: Beer Ya'acov Mental Health Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center, Ward B
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Bloemfontein
country: South Africa
facility: Oranje Hospital
state: Free State
city: Johannesburg
country: South Africa
facility: Rand Clinic
state: Gauteng
city: Pretoria
country: South Africa
facility: Private Practice
state: Gauteng
city: Cape Town
country: South Africa
facility: Flexivest fourteen Research Centre
state: W Cape
city: Cape Town
country: South Africa
facility: Cape Trial Centre
city: Natal
country: South Africa
facility: Crompton Medical Centre East
city: Pretoria West
country: South Africa
facility: Weskoppies Hospital
city: Chulalongkorn University
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Klongsan
country: Thailand
facility: Somdet Chaopraya Institute of Psychiatry
state: Bangkok
city: Muang
country: Thailand
facility: Suan Prung Psychiatric Hospital
state: Chiang Mai
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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/YIC.0b013e32835281ef.
citation: Patel PJ, Weidenfeller C, Jones AP, Nilsson J, Hsu J. Long-Term Assessment of Lurasidone in Schizophrenia: Post Hoc Analysis of a 12-Month, Double Blind, Active-Controlled Trial and 6-Month Open-Label Extension Study. Neurol Ther. 2021 Jun;10(1):121-147. doi: 10.1007/s40120-020-00221-4. Epub 2020 Oct 24.
citation: Mattingly GW, Haddad PM, Tocco M, Xu J, Phillips D, Pikalov A, Loebel A. Switching to Lurasidone following 12 months of treatment with Risperidone: results of a 6-month, open-label study. BMC Psychiatry. 2020 May 5;20(1):199. doi: 10.1186/s12888-020-02523-1.
citation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.