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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.
 
ClinicalTrials.gov Identifier: NCT00088621
Recruitment Status : Completed
First Posted : August 2, 2004
Results First Posted : May 6, 2011
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Description
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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 Design
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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
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Lurasidone

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


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

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00088621


Locations
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Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Medical Director, MD Sunovion
More Information
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00088621    
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:
Schizophrenia
Latuda
Lurasidone
Additional relevant MeSH terms:
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Schizophrenia
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