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

May 19, 2015 updated by: Sunovion

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

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
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates - Midwest Research
    • 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 Baptist Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide - Kirkbride Center
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Clinical Trials, LP
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Wharton, Texas, United States, 77488
        • Wharton Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine

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 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).

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 6 months
Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 6 months
Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289
6 months

Collaborators and Investigators

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

Sponsor

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

August 1, 2010

Primary Completion (ACTUAL)

November 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)

June 12, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050290

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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