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Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable 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: NCT00641745
Recruitment Status : Completed
First Posted : March 24, 2008
Results First Posted : October 6, 2011
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Description
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Brief Summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Lurasidone HCl Drug: Risperidone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long-Term Safety, Tolerability, and Effectiveness of Lurasidone in Subjects With Schizophrenia or Schizoaffective Disorder: A Randomized, Active Comparator-Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Lurasidone
 Drug: Lurasidone HCl
40 - 120mg per day
Active Comparator: 2
Risperidone
 Drug: Risperidone
Risperidone


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events. [ Time Frame: 12 months ]

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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

  • Subject is 18 to 75 years on the day of signing the consent form (age parameters may be restricted further per local requirements without protocol amendment).
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), undifferentiated (295.90), catatonic (295.20), or residual (295.60) or schizoaffective disorder (295.70) subtypes.
  • Subject is not pregnant or nursing, and is not planning pregnancy within the projected duration of the study.
  • Subject will comply with the study procedures and outpatient visit requirements in the opinion of the investigator.
  • Subject voluntarily agrees to participate in the study by giving written informed consent.

Main Exclusion Criteria:

To be excluded from entering this study if they fulfil any of the criteria below:

  • Subject has a chronic organic disease of the central nervous system (other than schizophrenia).
  • Subject has current clinically significant or history of, alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
  • In the opinion of the investigator, the subject has any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study.
  • Subject has participated in a study with an investigational compound or device within 30 days of signing informed consent.
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): NCT00641745


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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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00641745    
Other Study ID Numbers: D1050237
First Posted: March 24, 2008    Key Record Dates
Results First Posted: October 6, 2011
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Lurasidone Hydrochloride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists