A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents (SWITCHCore)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143077
First received: June 10, 2010
Last updated: April 9, 2013
Last verified: April 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 current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Lurasidone HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Time to Relapse of Psychotic Symptoms During 6 Weeks [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

    Relapse is defined as any occurrence of:

    • Insufficient clinical response
    • Exacerbation of underlying disease
    • Discontinuation due to an adverse event


Secondary Outcome Measures:
  • Tolerability and Safety [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
    Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events


Enrollment: 244
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone Open-Label Arm A Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda
Experimental: Lurasidone Open-Label Arm B Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda
Experimental: Lurasidone Open-Label Arm C Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda

  Eligibility

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

Inclusion Criteria:

  • Subject ≥ 18 years of age.
  • Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
  • Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.

Exclusion Criteria:

  • Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
  • Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
  • Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
  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: NCT01143077

  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
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, LLC
Lake Charles, Louisiana, United States, 70601
United States, Missouri
Saint Charles Psychiatric Associates/Midwest Research Group
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 Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
CRI Worldwide - Kirkbride Center
Philadelphia, Pennsylvania, United States, 19131
United States, Texas
FutureSearch Clinical Trials, LP
Austin, Texas, United States, 78731
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8828
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
Wharton Research Center
Houston, Texas, United States, 77488
United States, Utah
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Lurasidone Medical Director, MD Sunovion
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143077     History of Changes
Other Study ID Numbers: D1050289
Study First Received: June 10, 2010
Results First Received: May 15, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 19, 2014