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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143077
First received: June 10, 2010
Last updated: April 9, 2013
Last verified: April 2013
Results First Received: May 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Intervention: Drug: Lurasidone HCl

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
FPI June 24, 2010-LPV May 19, 2011, locations were private health clinics, university hospitals, private research facilities.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lurasidone Open-Label Arm 40/40 Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
Lurasidone Open-Label Arm 40/80 Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
Lurasidone Open-Label Arm 80/80 Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks

Participant Flow:   Overall Study
    Lurasidone Open-Label Arm 40/40     Lurasidone Open-Label Arm 40/80     Lurasidone Open-Label Arm 80/80  
STARTED     74     88     82  
COMPLETED     58     73     67  
NOT COMPLETED     16     15     15  
Lack of Efficacy                 0                 2                 1  
Adverse Event                 5                 6                 5  
Lost to Follow-up                 2                 3                 4  
Protocol Violation                 2                 0                 0  
Withdrawal by Subject                 4                 3                 3  
Non-compliance with study drug                 0                 1                 1  
Administrative                 1                 0                 0  
Principal Investigator Decision                 2                 0                 1  



  Baseline Characteristics


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

2.  Secondary:   Tolerability and Safety   [ Time Frame: 6 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information