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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
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
    Lurasidone Open-Label Arm 40/40     Lurasidone Open-Label Arm 40/80     Lurasidone Open-Label Arm 80/80     Total  
Number of Participants  
[units: participants]
  72     87     81     240  
Age [1]
[units: participants]
       
<=18 years     1     1     0     2  
Between 18 and 65 years     71     85     81     237  
>=65 years     0     1     0     1  
Age [1]
[units: years]
Mean ± Standard Deviation
  43.2  ± 11.3     44.0  ± 11.5     44.4  ± 10.0     43.9  ± 10.9  
Gender [1]
[units: participants]
       
Female     25     37     22     84  
Male     47     50     59     156  
Region of Enrollment [1]
[units: participants]
       
United States     72     87     81     240  
[1] 244 patients were randomized, 240 received study medication.



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

Measure Type Primary
Measure Title Time to Relapse of Psychotic Symptoms During 6 Weeks
Measure Description

Relapse is defined as any occurrence of:

  • Insufficient clinical response
  • Exacerbation of underlying disease
  • Discontinuation due to an adverse event
Time Frame 6 Weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intend to treat

Reporting Groups
  Description
Lurasidone Open-Label Arm 40/40 Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
Lurasidone Open-Label Arm 40/80 Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
Lurasidone Open-Label Arm 80/80 Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.

Measured Values
    Lurasidone Open-Label Arm 40/40     Lurasidone Open-Label Arm 40/80     Lurasidone Open-Label Arm 80/80  
Number of Participants Analyzed  
[units: participants]
  72     87     81  
Time to Relapse of Psychotic Symptoms During 6 Weeks  
[units: days]
Mean ± Standard Deviation
  23.8  ± 12.1     16.9  ± 11.6     17.3  ± 8.9  

No statistical analysis provided for Time to Relapse of Psychotic Symptoms During 6 Weeks



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

Measure Type Secondary
Measure Title Tolerability and Safety
Measure Description Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events
Time Frame 6 Weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lurasidone Open-Label Arm 40/40 Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
Lurasidone Open-Label Arm 40/80 Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
Lurasidone Open-Label Arm 80/80 Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.

Measured Values
    Lurasidone Open-Label Arm 40/40     Lurasidone Open-Label Arm 40/80     Lurasidone Open-Label Arm 80/80  
Number of Participants Analyzed  
[units: participants]
  72     87     81  
Tolerability and Safety  
[units: participants]
  72     87     81  

No statistical analysis provided for Tolerability and Safety




  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
No text entered.


  More Information