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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
478

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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