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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143090
First received: June 10, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Lurasidone HCl
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289


Enrollment: 149
Study Start Date: August 2010
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143090

  Hide Study Locations
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
University of California San Diego Medical Center
San Diego, California, United States, 92103-8218
California Neuropsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, United States, 92102
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
Sunovion
Investigators
Study Director: Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143090     History of Changes
Other Study ID Numbers: D1050290
Study First Received: June 10, 2010
Results First Received: November 15, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
Lurasidone
Latuda

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014