Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.
1 other identifier
interventional
478
5 countries
52
Brief Summary
Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.
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 Jan 2008
52 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
February 14, 2011
CompletedJune 12, 2015
May 1, 2015
1.9 years
February 1, 2008
November 8, 2010
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Baseline and 6 weeks
Secondary Outcomes (1)
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
6 weeks
Study Arms (4)
Lurasdione 40mg tablets
EXPERIMENTAL120mg
EXPERIMENTAL15mg Olz
ACTIVE COMPARATORSugar pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent and aged between 18 and 75 years of age.
- Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
- Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
- Able and agrees to remain off prior antipsychotic medication for the duration of study.
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.
You may not qualify if:
- Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
- Any chronic organic disease of the CNS (other than schizophrenia).
- Used investigational compound within 30 days.
- Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
K&S Professional Research Services LLC
Little Rock, Arkansas, 72201, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Clinical Pharmacological Studies, Inc.
Cerritos, California, 90703, United States
Excell Research
Oceanside, California, 92056, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
California Clinical Trials
Paramount, California, 90723, United States
CNRI - San Diego, LLC
San Diego, California, 92102, United States
UCSD Medical Center
San Diego, California, 92103, United States
Collaborative Neuroscience Network Inc.
Torrance, California, 90502, United States
Florida Clinical Research Center, LLC
Fruitland Park, Florida, 24731, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640, United States
Alexian Brothers Health System
Hoffman Estates, Illinois, 60169, United States
Lousiana Clinical Research, LLC
Shreveport, Louisiana, 71104, 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
CRI Worldwide @ Lourdes
Willingboro, New Jersey, 08046, United States
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516, United States
University of North Carolina at Chapel Hill
Raleigh, North Carolina, 27603, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19401, United States
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37212, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, 77008, United States
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
Cundinamarca, Bogota D.C., Colombia
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Barranquilla, Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogotá, Colombia
Centro de Investigaciones del Sistema Nervioso Limitada
Bogotá, Colombia
Psynapsis Salud Mental, S.A.
Risaralda, Colombia
Vijayawada Institute of Mental Health and Neurosciences
Vijaywada, Andh Prad, 520002, India
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, 530017, India
Hospital for Mental Health - Dept of Psychiatry
Ahmedabad, Gujarat, 380004, India
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, 380006, India
SBKS Medical College and Brij Psychiatry Hospital
Vadodara, Gujarat, 390001, India
Victoria Hospital
Bangalore, Karna, 56002, India
Kasturba Medical College
Mangalore, Karna, 575001, India
Father Muller Institute of Medical Education and Research
Mangalore, Karna, 575002, India
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, 575018, India
Kasturba Hospital
Manipal, Karna, 576104, India
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, 570004, India
Shanti Nursing Home
Aurangabad, Mahara, 431005, India
Deenanath Mangeshkar Hospital
Pune, Mahara, 411004, India
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003, India
Ziegzdriai Mental Hospital, Public Institution
Kaunas, 53136, Lithuania
Klaipeda Mental Hospital, Public Institution
Klaipėda, 91251, Lithuania
Siauliai Mental Hospital, Public Institution
Šiauliai, 76231, Lithuania
Republican Vilnius Psychiatry Hospital, Public Institution
Vilnius, 11205, Lithuania
Davao Medical School Foundation Hospital
Davao City, 8000, Philippines
Makati Medical Center
Makati City, 1227, Philippines
National Center for Mental Health
Mandaluyong, 1553, Philippines
Metro Psych Facility
Mandaue City, 6014, Philippines
Related Publications (5)
Meltzer HY, Cucchiaro J, Silva R, Ogasa M, Phillips D, Xu J, Kalali AH, Schweizer E, Pikalov A, Loebel A. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. Am J Psychiatry. 2011 Sep;168(9):957-67. doi: 10.1176/appi.ajp.2011.10060907. Epub 2011 Jun 15.
PMID: 21676992BACKGROUNDStahl SM, Cucchiaro J, Simonelli D, Hsu J, Pikalov A, Loebel A. Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. J Clin Psychiatry. 2013 May;74(5):507-15. doi: 10.4088/JCP.12m08084. Epub 2013 Mar 13.
PMID: 23541189RESULTHopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PMID: 39144777DERIVEDHopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PMID: 34751928DERIVEDNasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PMID: 24955752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Josephine Cucchiaro, Executive Director
- Organization
- Sunovion Pharmacetuicals Inc.
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
June 12, 2015
Results First Posted
February 14, 2011
Record last verified: 2015-05