Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

May 19, 2015 updated by: Sunovion

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

478

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Placebo comparator
Placebor Comparator
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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