Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia (PEARL 3 Ext)

May 19, 2015 updated by: Sunovion

A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

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
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bogota, Colombia
        • CISNE - UIC Campo Abierto
      • Bogota, Colombia
        • Centro de Investigación y Atención para la Salud Mental
      • Bogota, Colombia
        • Instituto Colombiano del Sistema Nervioso Clínica Montserrat
    • Barranquila S/N
      • Calle 80#47-43 Consultorio 5C, Barranquila S/N, Colombia
        • CIPNA Centro de Investigaciones y Proyectos en Neurociencias
    • Bogota S/N
      • Calle 103A # 21-49, Bogota S/N, Colombia
        • Centro de Investigación y Atención para la Salud Mental
  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Vijayawada Institute of Mental Health and Neurosciences
    • Andra Pradesh
      • Tirupati, Andra Pradesh, India, 517507
        • S.V. Medical College
    • Aurangabad, Maharashtra
      • Kanchanpalli, Aurangabad, Maharashtra, India
        • Shanti Nursing Home
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Seth K M School of P G Medicine & Research
      • Vadodara, Gujarat, India, 390001
        • SBKS Medical College and Hospital, Brij Psychiatry Hospital
    • Karna
      • Mangalore, Karna, India, 574160
        • Justice K.S. Hedge Charitable Hospital
      • Mysore, Karna, India, 570004
        • JSS Medical College and Hospital - Dept of Psychiatry
    • Maharashtra
      • Sewagram, Maharashtra, India
        • Mahatma Gandhi Institute of Medical Sciences
    • Maharastra
      • Pune, Maharastra, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
    • TamilNadu
      • Chennai, TamilNadu, India, 600003
        • Madras Medical College & Government General Hospital
  • Romania
      • Bucuresti, Romania
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
      • Oradea, Romania
        • Spitalul Clinic de Neurologie si Psihiatrie Oradea
      • Pitesti, Romania, 110069
        • Spitalul Judetean Arges
    • Arad
      • Str. Octavian Goga nr. 17, Arad, Romania, 310022
        • Spitalul Clinic Județean De Urgența Arad
    • Bucuresti
      • Sos. Berceni nr. 10-12, Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
  • Russian Federation
      • Gatchina, Russian Federation
        • Andreev, Boris
      • Moscow, Russian Federation
        • Gurovich, Isaak
      • Moscow, Russian Federation
        • Morozova, Margarita
      • Samara, Russian Federation
        • Sheifer, Mikhail
      • St-Petersburg, Russian Federation, 190005
        • City Psychoneurological Dispensary #7 (with Hospital)
      • St. Petersburg, Russian Federation, 191119
        • City Psychiatric Hospital #4
      • St. Petersburg, Russian Federation, 190121
        • City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets
      • St. Petersburg, Russian Federation, 197341
        • City Psychiatric Hospital #3 of Skvortsov-Stepanov
      • St. Petersburg, Russian Federation
        • Neznanov, Nikolay
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
      • Donetsk, Ukraine, 83037
        • Reg.Clin.Psychiatric Hosp., Dept. #11, DSMU n.af.M.Gorkiy
      • Kyiv, Ukraine, 04080
        • Kyiv City Clin. Psychoneurolog. Hosp.#1
      • Kyviv, Ukraine
        • Kyiv City Psychoneurological Hospital
      • Lviv, Ukraine
        • Lviv Reg.St.Cl.Psych.Hosp
      • Odessa, Ukraine
        • Reg. Psychiatric Hospital
      • Simferopol, Ukraine
        • Crimean republican Clinical Psychiatric Hospital
      • vil. Stepanovka, Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • 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.
      • Escondido, California, United States, 92025
        • Synergy Escondido,710 East Grand Ave.
      • Garden Grove, California, United States, 92645
        • Collaborative Neuroscience Network Inc
      • Long Beach, California, United States, 90813
        • Apostle Clinical Trials, Inc.
      • Paramount, California, United States, 90723
        • California Clinical Trials
      • Pasadena, California, United States, 91107
        • Pasadena Research Institute
      • Pico Rivera, California, United States, 90660
        • CNRI - Los Angeles LLC,8309 Telegraph Road
      • Pico Rivera, California, United States, 90660
        • CNRI- LOs Angeles, LLC
      • Riverside, California, United States, 92647
        • Clinical Innovations, Inc.
      • San Diego, California, United States, 92102
        • CNRI - San Diego
      • Sandeigo, California, United States, 92103
        • UCSD Medical Drive
    • Colorado
      • Highlands Ranch, Colorado, United States, 80103
        • Segal Institute for Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive NeuroScience, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center LLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
      • Shreveport, Louisiana, United States, 71104
        • Booker, J. Gary, MD. APMC
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates
      • St. Louis, Missouri, United States, 63118
        • St. Louis Research, Inc.
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide
    • New York
      • Brooklyn, New York, United States, 11238
        • SUNY Downstate Medical Center
      • Holliswood, New York, United States, 11423
        • Comprehensive Neuroscience, Inc
    • Texas
      • Austin, Texas, United States, 78729
        • Community Clinical Research
      • Austin, Texas, United States, 78756
        • FutureSearch Clinical Trials, LLC.
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research

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

Entry Criteria:

  • Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent.

Inclusion Criteria:

  • Completed all required assessments on the final study visit in Study D1050233.
  • Suitable for treatment in an outpatient setting.

Exclusion Criteria:

  • Any chronic organic disease of the CNS (other than schizophrenia).
  • Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quetiapine
Drug: Quetiapine XR
Quetiapine XR 200-800 mg/day flexibly dosed.
Experimental: Lurasidone HC1
Drug: Lurasidone HC1
Lurasidone 40-160 mg/day flexibly dosed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of Psychotic Symptoms
Time Frame: 12 Months

Time to relapse will be defined as the earliest occurrence of any of the following:

  • Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3
  • rehospitalization for worsening of psychosis
  • emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
Time Frame: Baseline and 6 Months
The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Baseline and 6 Months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
Time Frame: Baseline and 12 months
The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).
Baseline and 12 months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
Time Frame: Baseline and 12 months
The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
Baseline and 12 months

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

December 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 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

  • D1050234

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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