Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

June 5, 2014 updated by: Sunovion

A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

Lurasidone HCl is a compound being 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.
489

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

  • France
      • Nimes, France, 30000
        • Hospital Caremeau
  • India
    • Andh Prad
      • Tirupati, Andh Prad, India, 517507
        • S V Medical College
      • Visakhapatnam, Andh Prad, India, 530017
        • Government Hospital for Mental Care
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Sheth Vadilal Sarabhai General Hospital
    • Mahara
      • Aurangabad, Mahara, India, 431005
        • Shanti Nursing Home
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600003
        • Madras Medical College & Government General Hospital
    • Uttar Prad
      • Varanasi, Uttar Prad, India, 221005
        • Deva Mental Health Care
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Johor
      • Johor Bahru, Johor, Malaysia, 81200
        • Hospital Permai
  • Romania
      • Arad, Romania, 310022
        • Spitalul Clinic Județean De Urgența Arad
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
      • Bucuresti, Romania, 030442
        • Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
      • Gura Ocnitei, Romania, 130083
        • Centrul de Recuperare si Reabilitare Gura Ocnitei
      • Pitesti, Romania, 110069
        • Spitalul Judetean Arges
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163060
        • North State Medical University
      • Karelia, Russian Federation, 111111
        • Republic Psychiatric Hospital
      • St. Petersburg, Russian Federation, 191119
        • City Psychiatric Hospital #4
      • St. Petersburg, Russian Federation, 190005
        • City Psychoneurological Dispensary #7 (with Hospital)
      • St. Petersburg, Russian Federation, 190121
        • City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
      • St. Petersburg, Russian Federation, 193019
        • Bekhterev Psychoneurological Research Institute
      • St. Petersburg, Russian Federation, 197341
        • City Psychiatric Hospital #3 of Skvortsov-Stepanov
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
      • Donetsk, Ukraine, 83037
        • Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy
      • Kyiv, Ukraine, 04080
        • Kyiv City Clin. Psychoneurolog. Hosp.#1
      • Lviv, Ukraine, 79021
        • Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp
      • Odessa, Ukraine, 65006
        • Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1
      • vil. Stepanovka, Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • K&S Professional Research Services, LLC.
    • California
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience, Inc
      • Costa Mesa, California, United States, 92647
        • Clinical Innovations, Inc.
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
      • Paramount, California, United States, 90723
        • California Clinical Trials
      • Pasadena, California, United States, 91107
        • Pasadena Research Institute
      • Pico Rivera, California, United States, 90660
        • California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive NeuroScience, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Health System
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials LLC
      • Shreveport, Louisiana, United States, 71104
        • Booker, J. Gary, MD. APMC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Center for Behavioral Health, LLC
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center, Corp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide LLC at Kirkbride
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis, LLC.
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials of Neurology

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following 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
  • Masking: QUADRUPLE

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: Lurasidone HCl
Once daily
EXPERIMENTAL: Lurasidone 40mg
Drug: Lurasidone HCl
Once daily
EXPERIMENTAL: Lurasidone 80mg
Drug: Lurasidone HCl
Once daily
EXPERIMENTAL: Lurasidone 120mg
Drug: Lurasidone HCl
Once daily

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 Score From Baseline to the End of the Double Blind Phase
Time Frame: 6 weeks
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
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 From Baseline to the End of the Double-blind Treatment
Time Frame: 6 weeks
Clinical Global Impression of Severity 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. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
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.
October 1, 2007

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.
October 1, 2010

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.
October 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).
October 24, 2007

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.
October 25, 2007

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.
October 26, 2007

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 11, 2014

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.
June 5, 2014

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.
June 1, 2014

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.
  • D1050229
  • 2007-003819-31 (EUDRACT_NUMBER)

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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