A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Last updated: April 2, 2019
Sponsor: Sunovion
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

N/A

Clinical Study ID

NCT01566162
D1050307
2011-004790-90
  • Ages > 18
  • All Genders

Study Summary

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has agreed to participate by providing written informed consent.

  • Subject will be eligible to participate if one of the following criteria is met:

  • Subject has completed the 28-week double-blind phase of study D1050238

  • Subject has experienced a protocol-defined relapse event during the double- blindphase in study D1050238

  • Subject is participating in the open-label or double-blind phase of study D1050238if/when study D1050238 is terminated by the sponsor.

  • Subject has completed all required assessments on the final study visit (Study VisitNumber 42) in study D1050238.

  • Subject is judged by the Investigator to be suitable for participation in a 12-weekclinical trial involving open-label lurasidone treatment and is able to comply withthe protocol in the opinion of the Investigator.

Exclusion

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide or injuryto self, others, or property.

  • Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation withsome intent to act, without specific plan) or item 5 (active suicidal ideation withspecific plan and intent) on the C-SSRS at the extension baseline visit (Study VisitNumber 42 in study D1050238). Subjects who answer "yes" to this question must bereferred by the Investigator for appropriate follow-up evaluation and treatment.

  • Subject tests positive for drugs of abuse or is suspected of current alcohol abuse atthe extension baseline visit (Study Visit Number 42 in study D1050238). In the event asubject tests positive for cannabinoids, the Investigator will evaluate the subject'sability to abstain from cannabis during the study.

Study Design

Total Participants: 191
Study Start date:
April 01, 2012
Estimated Completion Date:
November 30, 2013

Study Description

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in Study D1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. Subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study D1050238 will have the option to participate in this study. In addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study D1050238 will have the option to participate in this extension study

Connect with a study center

  • Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)

    Dole, 39100
    France

    Site Not Available

  • Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

    Toulon, 83000
    France

    Site Not Available

  • Dipartimento Salute Mentale ASL 1

    Massa, 54100
    Italy

    Site Not Available

  • A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

    Pisa, 56100
    Italy

    Site Not Available

  • Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

    Lipetsk, 398007
    Russian Federation

    Site Not Available

  • Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'

    Rostov-on-Don, 344000
    Russian Federation

    Site Not Available

  • St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

    St. Peterburg, 191167
    Russian Federation

    Site Not Available

  • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7")

    St. Petersburg, 190005
    Russian Federation

    Site Not Available

  • St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

    St. Petersburg, 19005
    Russian Federation

    Site Not Available

  • St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

    St. Petersburg, 191119
    Russian Federation

    Site Not Available

  • Military Medical Academy, Clnic for Psychiatry

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute of Mental Health

    Dusica, 11000
    Serbia

    Site Not Available

  • Clinical Centre Kragujevac, Clinic for psychiatry

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinical Centre Nis, Clinic for mental health protection

    Nis, 18000
    Serbia

    Site Not Available

  • Specialized hospital for psychiatric diseases "Sveti Vracevi"

    Novi Knezevac, 23330
    Serbia

    Site Not Available

  • Clinical Centre Vojvodine, Clinic for Psychiatry

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

    Bojnice, 972 01
    Slovakia

    Site Not Available

  • Psychiatricka ambulancia Mentum s.r.o.

    Bratislava, 82007
    Slovakia

    Site Not Available

  • Psychiatricka nemocnica Michalovce n.o.

    Michalovce, 071 01
    Slovakia

    Site Not Available

  • PsychoLine s.r.o. Psychiatricka ambulancia

    Rimavska Sobota, 97901
    Slovakia

    Site Not Available

  • Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

    Roznava, 048 01
    Slovakia

    Site Not Available

  • "Centrum zdravia R.B.K., spol. s.r.o.

    Svidnik, 089 01
    Slovakia

    Site Not Available

  • Cape Trial Centre

    Tygervalley, Western Cape 7530
    South Africa

    Site Not Available

  • Research Unit, Department of Psychiatry Free State Psychiatric Complex

    Bloemfontein, 9300
    South Africa

    Site Not Available

  • Denmar Hospital Consulting Rooms

    Pretoria, 0081
    South Africa

    Site Not Available

  • Woodland Research Northwest

    Springdale, Arizona 72764
    United States

    Site Not Available

  • K and S Professional Research Services

    Little Rock, Arkansas 72201
    United States

    Site Not Available

  • Woodland International Research Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Comprehensive Clinical Development Inc.

    Cerritos, California 90703
    United States

    Site Not Available

  • Diligent Clinical Trials

    Downey, California 90241
    United States

    Site Not Available

  • Synergy Clinical Research Center

    Escondido, California 92025
    United States

    Site Not Available

  • CNS Network

    Garden Grove, California 92845
    United States

    Site Not Available

  • AXIS Clinical Trials

    Los Angeles, California 90036
    United States

    Site Not Available

  • Synergy Clinical Research Center

    National City, California 91950
    United States

    Site Not Available

  • Excell Research, Inc.

    Oceanside, California 92056
    United States

    Site Not Available

  • CNRI-Los Angeles. LLC

    Pico Rivera, California 90660
    United States

    Site Not Available

  • California Neuropsychopharmacolgoy Clinical Research Insitute

    San Diego, California 92126
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California 92701
    United States

    Site Not Available

  • Collaborative Neuroscience Network

    Torrance, California 90502
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Accurate Clinical Trials

    Kissimme, Florida 34742
    United States

    Site Not Available

  • Accurate Clinical Trials

    Kissimmee, Florida 34742
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Maitland, Florida 32751
    United States

    Site Not Available

  • Galiz Research

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Medical Research Group of Central Florida

    Orange City, Florida 32763
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Comprehensive NeuroScience Inc.

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Lousiana Clinical Research, LLC

    Shreveport, Louisiana 71104
    United States

    Site Not Available

  • Center for Behavioral Health, LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Psychiatric Care and Research Center

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • Psych Care Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • St. Charles Psychiatric Associates - Midwest Research

    St. Charles, Missouri 63301
    United States

    Site Not Available

  • Psych Care Consultants Research

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Robert Lynn Horne, MD

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • CRI Worldwide LLC

    Willingboro, New Jersey 08046
    United States

    Site Not Available

  • Erie County Medical Center, Corp

    Buffalo, New York 14215
    United States

    Site Not Available

  • Neurobehavioral Research Inc.

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • Behavioral Medical Research of Staten Island

    Staten Island, New York 10305
    United States

    Site Not Available

  • Oklahoma Clinical Research

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • CRI Worldwide LLC at Kirkbride

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • Lincoln Research

    Lincoln, Rhode Island 02865
    United States

    Site Not Available

  • Community Clinical Research, Inc.

    Austin, Texas 78754
    United States

    Site Not Available

  • FutureSearch Clinical Trials LP

    Austin, Texas 78756
    United States

    Site Not Available

  • FutureSearch Clinical Trials, LP

    Dallas, Texas 75231
    United States

    Site Not Available

  • Pillar Clinical Research, LLC

    Dallas, Texas 75243
    United States

    Site Not Available

  • Family Psychiatry of the Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Department of Psychiatry, University of Utah Health Sciences Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Frontier Institute

    Spokane, Washington 99204
    United States

    Site Not Available

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