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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088621
Recruitment Status : Completed
First Posted : August 2, 2004
Results First Posted : May 6, 2011
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone 80mg tablet Phase 2

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  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
Study Start Date : July 2004
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lurasidone 80 mg tablet
Lurasidone 80mg oral tablet taken once a day
Drug: Lurasidone 80mg tablet
Other Name: Lurasidone

Primary Outcome Measures :
  1. Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088621

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
California Clinical Trials
San Diego, California, United States, 92123
CA Neutopsychopharmacology Clinical Research Institute (CNRI)
San Diego, California, United States, 92126
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
Community Clinical Research
Austin, Texas, United States, 78729
Future Search Trials
Austin, Texas, United States, 78756
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
Study Director: Medical Director, MD Sunovion

Responsible Party: Sunovion Identifier: NCT00088621     History of Changes
Other Study ID Numbers: D1050199
First Posted: August 2, 2004    Key Record Dates
Results First Posted: May 6, 2011
Last Update Posted: April 17, 2014
Last Verified: March 2014

Keywords provided by Sunovion:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents