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

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Intervention: Drug: Lurasidone HCl

  Participant Flow

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
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

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

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