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Safety and Tolerability Study of Drug to Treat 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: NCT00044005
Recruitment Status : Completed
First Posted : August 20, 2002
Results First Posted : May 19, 2011
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Description
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Brief Summary:
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone 20 mg Drug: Lurasidone 40 mg Drug: Lurasidone 80mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia
Study Start Date : September 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

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 20 mg
Lurasidone 20 mg oral tablet
 Drug: Lurasidone 20 mg
Lurasidone 20mg oral tablet taken once daily for 6-months
Experimental: Lurasidione 40 mg
Lurasidone 40 mg oral tablet
 Drug: Lurasidone 40 mg
Lurasidone 40mg oral tablets taken once daily
Experimental: Lurasidone 80mg
Lurasidone 80mg oral tablet
 Drug: Lurasidone 80mg
Lurasidone 80mg oral tablet taken once daily


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6-months ]
    The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.


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

Inclusion criteria:

  • Successful completion of participation in protocol #D1050049

Exclusion criteria:

  • Substance abuse
  • Prolactin level of ≥200ng/mL at baseline
  • Pregnancy
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): NCT00044005


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: NCT00044005    
Other Study ID Numbers: D1050174
First Posted: August 20, 2002    Key Record Dates
Results First Posted: May 19, 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