Clinical trial NCT00615433: Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 478
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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
timeFrame: 6 weeks
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: Cerritos
country: United States
facility: Clinical Pharmacological Studies, Inc.
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: Paramount
country: United States
facility: California Clinical Trials
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network Inc.
state: California
city: Fruitland Park
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Health System
state: Illinois
city: Shreveport
country: United States
facility: Lousiana Clinical Research, LLC
state: Louisiana
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: Willingboro
country: United States
facility: CRI Worldwide @ Lourdes
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc.
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: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Inc.
state: Texas
city: Cundinamarca
country: Colombia
facility: Instituto Colombiano del Sistema Nervioso Clinica Montserrat
state: Bogota
city: Barranquilla
country: Colombia
facility: CIPNA Centro de Investigaciones y Proyectos en Neurociencias
city: Bogota
country: Colombia
facility: Centro de Investigacion y Atencion para la Salud Mental
city: Bogota
country: Colombia
facility: Centro de Investigaciones del Sistema Nervioso Limitada
city: Risaralda
country: Colombia
facility: Psynapsis Salud Mental, S.A.
city: Vijaywada
country: India
facility: Vijayawada Institute of Mental Health and Neurosciences
state: Andh Prad
city: Visakhapatnam
country: India
facility: Government Hospital for Mental Care
state: Andh Prad
city: Ahmedabad
country: India
facility: Hospital for Mental Health - Dept of Psychiatry
state: Gujarat
city: Ahmedabad
country: India
facility: Sheth Vadilal Sarabhai General Hospital
state: Gujarat
city: Vadodara
country: India
facility: SBKS Medical College and Brij Psychiatry Hospital
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital
state: Karna
city: Mangalore
country: India
facility: Kasturba Medical College
state: Karna
city: Mangalore
country: India
facility: Father Muller Institute of Medical Education and Research
state: Karna
city: Mangalore
country: India
facility: Justice K.S. Hedge Charitable Hospital
state: Karna
city: Manipal
country: India
facility: Kasturba Hospital
state: Karna
city: Mysore
country: India
facility: JSS Medical College and Hospital - Dept of Psychiatry
state: Karna
city: Aurangabad
country: India
facility: Shanti Nursing Home
state: Mahara
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
state: Mahara
city: Chennai
country: India
facility: Madras Medical College & Government General Hospital
state: TamilNadu
city: Kaunas
country: Lithuania
facility: Ziegzdriai Mental Hospital, Public Institution
city: Klaipeda
country: Lithuania
facility: Klaipeda Mental Hospital, Public Institution
city: Siauliai
country: Lithuania
facility: Siauliai Mental Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Republican Vilnius Psychiatry Hospital, Public Institution
city: Davao City
country: Philippines
facility: Davao Medical School Foundation Hospital
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Mandaluyong City
country: Philippines
facility: National Center for Mental Health
city: Mandaue City
country: Philippines
facility: Metro Psych Facility
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Stahl 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.
citation: Hopkins 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.
citation: Nasrallah 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.