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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
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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
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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 
Overall Participants Analyzed 
[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 
[1] 244 patients were randomized, 240 received study medication.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 43.2  (11.3)   44.0  (11.5)   44.4  (10.0)   43.9  (10.9) 
[1] 244 patients were randomized, 240 received study medication.
Gender [1] 
[Units: Participants]
       
Female   25   37   22   84 
Male   47   50   59   156 
[1] 244 patients were randomized, 240 received study medication.
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 ]

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Lurasidone Open-Label Arm 40/40   Lurasidone Open-Label Arm 40/80   Lurasidone Open-Label Arm 80/80
Total, other (not including serious) adverse events       
# participants affected / at risk   45/72 (62.50%)   62/87 (71.26%)   59/81 (72.84%) 
Gastrointestinal disorders       
Nausea †       
# participants affected / at risk   10/72 (13.89%)   8/87 (9.20%)   15/81 (18.52%) 
# events   17   8   23 
Vomiting †       
# participants affected / at risk   4/72 (5.56%)   6/87 (6.90%)   7/81 (8.64%) 
# events   4   7   10 
Dry Mouth †       
# participants affected / at risk   3/72 (4.17%)   9/87 (10.34%)   2/81 (2.47%) 
# events   3   10   2 
General disorders       
Fatigue †       
# participants affected / at risk   3/72 (4.17%)   5/87 (5.75%)   2/81 (2.47%) 
# events   3   5   2 
Nervous system disorders       
Akathisia †       
# participants affected / at risk   6/72 (8.33%)   13/87 (14.94%)   11/81 (13.58%) 
# events   6   17   13 
Headache       
# participants affected / at risk   7/72 (9.72%)   10/87 (11.49%)   6/81 (7.41%) 
# events   13   10   8 
Sedation †       
# participants affected / at risk   3/72 (4.17%)   2/87 (2.30%)   5/81 (6.17%) 
# events   3   2   5 
Somnolence †       
# participants affected / at risk   7/72 (9.72%)   7/87 (8.05%)   2/81 (2.47%) 
# events   9   7   3 
Dizziness †       
# participants affected / at risk   4/72 (5.56%)   0/87 (0.00%)   0/81 (0.00%) 
# events   4   0   0 
Psychiatric disorders       
Anxiety †       
# participants affected / at risk   2/72 (2.78%)   6/87 (6.90%)   1/81 (1.23%) 
# events   2   6   1 
Insomnia †       
# participants affected / at risk   3/72 (4.17%)   16/87 (18.39%)   12/81 (14.81%) 
# events   4   16   12 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment



  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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