Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00615433
First received: February 1, 2008
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Lurasidone
Drug: Olanzapine
Drug: Placebo comparator
Drug: Lurasidone 40 mg tablets
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 478
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasdione 40mg tablets Drug: Lurasidone 40 mg tablets
Lurasidone 40 mg tablets
Experimental: 120mg Drug: Lurasidone
120mg/day
Active Comparator: 15mg Olz Drug: Olanzapine
15mg/day
Placebo Comparator: Sugar pill Drug: Placebo comparator
Placebor Comparator

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615433

  Hide Study Locations
Locations
United States, Arkansas
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
K&S Professional Research Services LLC
Little Rock, Arkansas, United States, 72201
United States, California
Clinical Pharmacological Studies, Inc.
Cerritos, California, United States, 90703
Excell Research
Oceanside, California, United States, 92056
University of California at Irvine Medical Center
Orange, California, United States, 92868
California Clinical Trials
Paramount, California, United States, 90723
UCSD Medical Center
San Diego, California, United States, 92103
CNRI - San Diego, LLC
San Diego, California, United States, 92102
Collaborative Neuroscience Network Inc.
Torrance, California, United States, 90502
United States, Florida
Florida Clinical Research Center, LLC
Fruitland Park, Florida, United States, 24731
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Uptown Research Institute, LLC
Chicago, Illinois, United States, 60640
Alexian Brothers Health System
Hoffman Estates, Illinois, United States, 60169
United States, Louisiana
Lousiana Clinical Research, LLC
Shreveport, Louisiana, United States, 71104
United States, Mississippi
Precise Research Center
Flowood, Mississippi, United States, 39232
United States, Missouri
St. Charles Psychiatric Associates-Midwest Research
St. Charles, Missouri, United States, 63301
St. Louis Clinical Trials
St. Louis, Missouri, United States, 63118
United States, New Jersey
CRI Worldwide @ Lourdes
Willingboro, New Jersey, United States, 08046
United States, New York
Neurobehavioral Research Inc.
Cedarhurst, New York, United States, 11516
United States, North Carolina
University of North Carolina at Chapel Hill
Raleigh, North Carolina, United States, 27603
United States, Pennsylvania
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States, 19401
United States, Tennessee
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37212
United States, Texas
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
Claghorn-Lesem Research Clinic, Inc.
Houston, Texas, United States, 77008
Colombia
Instituto Colombiano del Sistema Nervioso Clinica Montserrat
Cundinamarca, Bogota, Colombia
CIPNA Centro de Investigaciones y Proyectos en Neurociencias
Barranquilla, Colombia
Centro de Investigaciones del Sistema Nervioso Limitada
Bogota, Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogota, Colombia
Psynapsis Salud Mental, S.A.
Risaralda, Colombia
India
Vijayawada Institute of Mental Health and Neurosciences
Vijaywada, Andh Prad, India, 520002
Government Hospital for Mental Care
Visakhapatnam, Andh Prad, India, 530017
Hospital for Mental Health - Dept of Psychiatry
Ahmedabad, Gujarat, India, 380004
Sheth Vadilal Sarabhai General Hospital
Ahmedabad, Gujarat, India, 380006
SBKS Medical College and Brij Psychiatry Hospital
Vadodara, Gujarat, India, 390001
Victoria Hospital
Bangalore, Karna, India, 56002
Kasturba Medical College
Mangalore, Karna, India, 575001
Justice K.S. Hedge Charitable Hospital
Mangalore, Karna, India, 575018
Father Muller Institute of Medical Education and Research
Mangalore, Karna, India, 575002
Kasturba Hospital
Manipal, Karna, India, 576104
JSS Medical College and Hospital - Dept of Psychiatry
Mysore, Karna, India, 570004
Shanti Nursing Home
Aurangabad, Mahara, India, 431005
Deenanath Mangeshkar Hospital
Pune, Mahara, India, 411004
Madras Medical College & Government General Hospital
Chennai, TamilNadu, India, 600003
Lithuania
Ziegzdriai Mental Hospital, Public Institution
Kaunas, Lithuania, 53136
Klaipeda Mental Hospital, Public Institution
Klaipeda, Lithuania, 91251
Siauliai Mental Hospital, Public Institution
Siauliai, Lithuania, 76231
Republican Vilnius Psychiatry Hospital, Public Institution
Vilnius, Lithuania, 11205
Philippines
Davao Medical School Foundation Hospital
Davao City, Philippines, 8000
Makati Medical Center
Makati City, Philippines, 1227
National Center for Mental Health
Mandaluyong City, Philippines, 1553
Metro Psych Facility
Mandaue City, Philippines, 6014
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

Publications:
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00615433     History of Changes
Other Study ID Numbers: D1050231
Study First Received: February 1, 2008
Results First Received: November 8, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
Latuda
Lurasidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014