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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

489

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

  • 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

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
Intervention / Treatment
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

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

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

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

October 1, 2007

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (ESTIMATE)

October 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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