Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Schizophrenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615433
• Other study ID #: D1050231
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: May 19, 2015
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: May 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone
120mg/day
• Olanzapine
15mg/day
• Placebo comparator
Placebor Comparator
• Lurasidone 40 mg tablets
Lurasidone 40 mg tablets

Locations

Country	Name	City	State
Colombia	CIPNA Centro de Investigaciones y Proyectos en Neurociencias	Barranquilla
Colombia	Centro de Investigacion y Atencion para la Salud Mental	Bogota
Colombia	Centro de Investigaciones del Sistema Nervioso Limitada	Bogota
Colombia	Instituto Colombiano del Sistema Nervioso Clinica Montserrat	Cundinamarca	Bogota
Colombia	Psynapsis Salud Mental, S.A.	Risaralda
India	Hospital for Mental Health - Dept of Psychiatry	Ahmedabad	Gujarat
India	Sheth Vadilal Sarabhai General Hospital	Ahmedabad	Gujarat
India	Shanti Nursing Home	Aurangabad	Mahara
India	Victoria Hospital	Bangalore	Karna
India	Madras Medical College & Government General Hospital	Chennai	TamilNadu
India	Father Muller Institute of Medical Education and Research	Mangalore	Karna
India	Justice K.S. Hedge Charitable Hospital	Mangalore	Karna
India	Kasturba Medical College	Mangalore	Karna
India	Kasturba Hospital	Manipal	Karna
India	JSS Medical College and Hospital - Dept of Psychiatry	Mysore	Karna
India	Deenanath Mangeshkar Hospital	Pune	Mahara
India	SBKS Medical College and Brij Psychiatry Hospital	Vadodara	Gujarat
India	Vijayawada Institute of Mental Health and Neurosciences	Vijaywada	Andh Prad
India	Government Hospital for Mental Care	Visakhapatnam	Andh Prad
Lithuania	Ziegzdriai Mental Hospital, Public Institution	Kaunas
Lithuania	Klaipeda Mental Hospital, Public Institution	Klaipeda
Lithuania	Siauliai Mental Hospital, Public Institution	Siauliai
Lithuania	Republican Vilnius Psychiatry Hospital, Public Institution	Vilnius
Philippines	Davao Medical School Foundation Hospital	Davao City
Philippines	Makati Medical Center	Makati City
Philippines	National Center for Mental Health	Mandaluyong City
Philippines	Metro Psych Facility	Mandaue City
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Neurobehavioral Research Inc.	Cedarhurst	New York
United States	Clinical Pharmacological Studies, Inc.	Cerritos	California
United States	Uptown Research Institute, LLC	Chicago	Illinois
United States	Precise Research Center	Flowood	Mississippi
United States	Florida Clinical Research Center, LLC	Fruitland Park	Florida
United States	Alexian Brothers Health System	Hoffman Estates	Illinois
United States	Claghorn-Lesem Research Clinic, Inc.	Houston	Texas
United States	K&S Professional Research Services LLC	Little Rock	Arkansas
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	Keystone Clinical Studies, LLC	Norristown	Pennsylvania
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Excell Research	Oceanside	California
United States	University of California at Irvine Medical Center	Orange	California
United States	California Clinical Trials	Paramount	California
United States	University of North Carolina at Chapel Hill	Raleigh	North Carolina
United States	CNRI - San Diego, LLC	San Diego	California
United States	UCSD Medical Center	San Diego	California
United States	Lousiana Clinical Research, LLC	Shreveport	Louisiana
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	CRI Worldwide @ Lourdes	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Colombia,  India,  Lithuania,  Philippines, 

References & Publications (2)

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. — View 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 Psychi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.	The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.	6 weeks	No