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A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents (SWITCHCore)

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ClinicalTrials.gov Identifier: NCT01143077
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : August 16, 2012
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, 6-week, Open-Label, Study Evaluating The Safety, Tolerability, and Efficacy of Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents
Study Start Date : June 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lurasidone Open-Label Arm A Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda
Experimental: Lurasidone Open-Label Arm B Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda
Experimental: Lurasidone Open-Label Arm C Drug: Lurasidone HCl
Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
Other Name: Latuda


Outcome Measures

Primary Outcome Measures :
  1. Time to Relapse of Psychotic Symptoms During 6 Weeks [ Time Frame: 6 Weeks ]

    Relapse is defined as any occurrence of:

    • Insufficient clinical response
    • Exacerbation of underlying disease
    • Discontinuation due to an adverse event


Secondary Outcome Measures :
  1. Tolerability and Safety [ Time Frame: 6 Weeks ]
    Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject ≥ 18 years of age.
  • Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder.
  • Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns.

Exclusion Criteria:

  • Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening.
  • Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening.
  • Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).
Contacts and Locations

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): NCT01143077


  Show 27 Study Locations
Sponsors and Collaborators
Sunovion
Investigators
Study Director: Lurasidone Medical Director, MD Sunovion
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143077     History of Changes
Other Study ID Numbers: D1050289
First Posted: June 14, 2010    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Sunovion:
Lurasidone
Schizophrenia
Latuda

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Lurasidone Hydrochloride
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