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

April 9, 2013 updated by: Sunovion

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • K and S Professional Research Services
    • California
      • Escondido, California, United States, 92025
        • Synergy Clinical Research of Escondido
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Oakland, California, United States, 94612
        • Pacific Research Partners, LLC
      • Paramount, California, United States, 90723
        • California Clinical Trials
      • Pasadena, California, United States, 91107
        • Pasadena Research Institute
      • Pico Rivera, California, United States, 90660
        • California Neuropsychopharmacology Clinical Research Institute (CNRI), LLC
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical Research Institute (CNRI)
      • San Diego, California, United States, 92103-8218
        • University of California San Diego Medical Center
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network, South Bay
    • Colorado
      • Denver, Colorado, United States, 80204
        • Western Affiliated Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Comprehensive NeuroScience, Inc.
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Lake Charles Clinical Trials, LLC
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Saint Charles Psychiatric Associates/Midwest Research Group
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • Glen Oaks, New York, United States, 11004
        • The Zucker Hillside Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Dept. of Psychiatry
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19131
        • CRI Worldwide - Kirkbride Center
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Clinical Trials, LP
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Dallas, Texas, United States, 75390-8828
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77488
        • Wharton Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospitals and Clinics

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lurasidone Open-Label Arm A
Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Names:
  • 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 Names:
  • 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 Names:
  • Latuda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Relapse of Psychotic Symptoms During 6 Weeks
Time Frame: 6 Weeks

Relapse is defined as any occurrence of:

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability and Safety
Time Frame: 6 Weeks
Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Investigators

  • Study Director: Lurasidone Medical Director, MD, 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

June 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050289

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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