Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
1 other identifier
interventional
629
8 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Mar 2008
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
October 6, 2011
CompletedJune 22, 2015
June 1, 2015
2.3 years
March 18, 2008
September 1, 2011
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events.
12 months
Study Arms (2)
1
EXPERIMENTALLurasidone
2
ACTIVE COMPARATORRisperidone
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
K&S Professional Research Services LLC
Little Rock, Arkansas, 72201, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
South Coast Clinical Trials, Inc.
Anaheim, California, 92804, United States
Comprehensive NeuroScience, Inc. - Cerritos
Cerritos, California, 90703, United States
Clinical Innovations Inc.
Costa Mesa, California, 92626, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, 92845, United States
University of Southern California
Los Angeles, California, 90033, United States
Excell Research
Oceanside, California, 92056, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
Pasadena Research Institute
Pasadena, California, 91107, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, 90660, United States
Clinical Innovations Inc.
Riverside, California, 92506, United States
CNRI-San Diego LLC
San Diego, California, 92102, United States
UCSD, Outpatient Psychiatric Services
San Diego, California, 92103, United States
Clinical Innovations Inc.
Santa Ana, California, 92705, United States
Collaborative Neuroscience Network Inc
Torrance, California, 90502, United States
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, 20016, United States
Fidelity Clinical Research Inc., c/o Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Fidelity Clinical Research Inc.
North Miami, Florida, 33161, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Northlake Medical Research Center
Tucker, Georgia, 30084, United States
Alexian Brothers Medical Center
Hoffman Estates, Illinois, 60169, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601, United States
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
Precise Research Center
Flowood, Mississippi, 39232, United States
St. Charles Psychiatric Associates - Midwest Research
Saint Charles, Missouri, 63301, United States
St. Louis Clinical Trials
St Louis, Missouri, 63118, United States
Creighton University
Omaha, Nebraska, 68131, United States
CRI Worldwide
Willingboro, New Jersey, 08046, United States
SUNY Downstate University
Brooklyn, New York, 11203, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516, United States
Manhattan Psychiatric Center
New York, New York, 10035, United States
Social Psychiatry Research Institute
New York, New York, 10454, United States
University of North Carolina at Chapel Hill
Raleigh, North Carolina, 27603, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
Research Strategies of Memphis LLC
Memphis, Tennessee, 38119, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Pillar Clinical Research LLC
Dallas, Texas, 75243, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008, United States
Alliance Research Group
Richmond, Virginia, 23230, United States
Fundación para el Estudio y Tratamiento de las Enf. Mentales
Capital Federal, BUE, C1425AHP, Argentina
Clinica Privada Neuropsiquiatrica San Agustin
La Plata, BUE, 1900, Argentina
Resolution Psychopharmacology Research Institute
Mendoza, MEN, M5502HLE, Argentina
CIAP
Rosario, SFE, S2000QJI, Argentina
Sanatorio 'Prof. Leon S. Morra' S.A.
Córdoba, X5009BIN, Argentina
Sanatorio Sao Paulo
Salvador, Estado de Bahia, 40301-500, Brazil
Hospital Espirita de Psiquiatria Bom Retiro
Curitiba, Paraná, 80520-000, Brazil
Hospital Mario Kroeff
Rio de Janeiro, Rio de Janeiro, 21020-130, Brazil
PAX Clinica Psiquiatrica Ltda
Aparecida de Goiânia, 74922-810, Brazil
Hospital Clincio Felix Bulnes
Quinta Normal, Santiago Metropolitan, Chile
Instituto Psiquiátrico Dr. José Horwitz Barak
Recoleta, Santiago Metropolitan, Chile
Hospital Barros Luco Trudeau
San Miguel, Santiago Metropolitan, Chile
CIPAM - Clínica Pedro Montt
Santiago, Santiago Metropolitan, Chile
Hospital Base Valdivia
Valdivia, Valdivia, Chile
Psychiatric Hospital Vrapce
Zagreb, City of Zagreb, 10 090, Croatia
Croatian institute for brain research Neuron
Zagreb, City of Zagreb, 10000, Croatia
Clinical Hospital Centre Rijeka
Rijeka, Rijeka, 51 000, Croatia
Beer Ya'acov Mental Health Center
Beer Yaakov, Beer Yaakov, 70300, Israel
Rambam Health Care Campus
Haifa, Haifa District, 31096, Israel
Shalvata Mental Health Center
Hod HaSharon, Hod Hasharon, 45100, Israel
Chaim Sheba Medical Center
Ramat Gan, Ramat Gan, 52621, Israel
Shalvata Mental Health Center, Ward B
Hod HaSharon, 45100, Israel
Oranje Hospital
Bloemfontein, Free State, 9301, South Africa
Rand Clinic
Johannesburg, Gauteng, 2198, South Africa
Private Practice
Pretoria, Gauteng, 0181, South Africa
Flexivest fourteen Research Centre
Cape Town, W Cape, 7535, South Africa
Cape Trial Centre
Cape Town, 7530, South Africa
Crompton Medical Centre East
Natal, 3600, South Africa
Weskoppies Hospital
Pretoria West, 0001, South Africa
King Chulalongkorn Memorial Hospital
Chulalongkorn University, Bangkok, Thailand
Somdet Chaopraya Institute of Psychiatry
Klongsan, Bangkok, Thailand
Suan Prung Psychiatric Hospital
Muang, Chiang Mai, Thailand
Related Publications (5)
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.
PMID: 21075600BACKGROUNDCitrome 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.
PMID: 22395527RESULTPatel 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.
PMID: 33098548DERIVEDMattingly 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.
PMID: 32370778DERIVEDGeorgiades 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.
PMID: 28433500DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, PhD; Executive Director
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
June 22, 2015
Results First Posted
October 6, 2011
Record last verified: 2015-06