A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

March 31, 2014 updated by: Sunovion

An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia

A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Psychiatry Pharmaceutical
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Summit Research Group
    • California
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience
      • Garden Grove, California, United States, 92845
        • Collaborative Neuro Science Network, Inc.
      • La Mesa, California, United States, 91942
        • Optimum Health Services
      • San Diego, California, United States, 92123
        • California Clinical Trials
      • San Diego, California, United States, 92126
        • CA Neutopsychopharmacology Clinical Research Institute (CNRI)
      • Upland, California, United States, 91786
        • Pacific Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive Neuroscience, Inc
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
        • Segal Institute for Clinical Research
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • Tampa, Florida, United States, 33613
        • University of South Florida, Department of Psychiatry and Behavioral Medicine
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
        • Comprehensive NeuroScience, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Cns Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Quantum Clinical Services Group
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials
      • Austin, Texas, United States, 78729
        • Community Clinical Research
      • Bellaire, Texas, United States, 77401
        • Claghorn Lesem Research Clinic, Inc.
      • DeSoto, Texas, United States, 75115
        • Insite clinical research
    • Virginia
      • Falls Church, Virginia, United States, 22044
        • CBH Health, L.L.C - Dominion Hospital

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 to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either:
  • Successfully completed
  • OR
  • Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lurasidone 80 mg tablet
Lurasidone 80mg oral tablet taken once a day
Drug: Lurasidone 80mg tablet
Other Names:
  • Lurasidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sunovion

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

July 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

July 30, 2004

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050199

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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