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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00088621
First received: July 30, 2004
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Lurasidone 80mg tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: July 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lurasidone 80 mg tablet
Lurasidone 80mg oral tablet taken once a day
Drug: Lurasidone 80mg tablet
Other Name: Lurasidone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088621

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

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00088621     History of Changes
Other Study ID Numbers: D1050199
Study First Received: July 30, 2004
Results First Received: February 11, 2011
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Schizophrenia
Latuda
Lurasidone

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

ClinicalTrials.gov processed this record on April 17, 2014