A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01143090
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : December 17, 2012
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):

Brief Summary:
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Lurasidone HCl Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-Week, Flexible-Dose, Open-label Extension Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Protocol No. D1050290)
Study Start Date : August 2010
Actual Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open Label
Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
Drug: Lurasidone HCl
40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months ]
    Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 6 months ]
    Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria:

  • Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
  • Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01143090

  Hide Study Locations
United States, Arkansas
K and S Professional Research Services
Little Rock, Arkansas, United States, 72201
United States, California
Synergy Clinical Research of Escondido
Escondido, California, United States, 92025
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
Pacific Research Partners, LLC
Oakland, California, United States, 94612
California Clinical Trials
Paramount, California, United States, 90723
Pasadena Research Institute
Pasadena, California, United States, 91107
California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
Pico Rivera, California, United States, 90660
California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, United States, 92102
University of California San Diego Medical Center
San Diego, California, United States, 92103-8218
Collaborative Neuroscience Network, South Bay
Torrance, California, United States, 90502
United States, Colorado
Western Affiliated Research Institute
Denver, Colorado, United States, 80204
United States, Georgia
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States, 30328
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70601
United States, Missouri
St. Charles Psychiatric Associates - Midwest Research
St. Charles, Missouri, United States, 63301
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
United States, North Carolina
Duke University Dept. of Psychiatry
Durham, North Carolina, United States, 27710
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
FutureSearch Clinical Trials, LP
Austin, Texas, United States, 78731
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Wharton Research Center
Wharton, Texas, United States, 77488
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Study Director: Medical Director, MD Sunovion

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT01143090     History of Changes
Other Study ID Numbers: D1050290
First Posted: June 14, 2010    Key Record Dates
Results First Posted: December 17, 2012
Last Update Posted: June 12, 2015
Last Verified: May 2015

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents