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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):
Sunovion

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
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

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

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

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


  Serious Adverse Events

Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Lurasidone Open-Label Arm 40/40   Lurasidone Open-Label Arm 40/80   Lurasidone Open-Label Arm 80/80
Total, Serious Adverse Events       
# participants affected / at risk   3/72 (4.17%)   2/87 (2.30%)   0/81 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis †       
# participants affected / at risk   1/72 (1.39%)   0/87 (0.00%)   0/81 (0.00%) 
# events   1   0   0 
Psychiatric disorders       
Alcoholism †       
# participants affected / at risk   0/72 (0.00%)   1/87 (1.15%)   0/81 (0.00%) 
# events   0   1   0 
Schizoaffective disorder †       
# participants affected / at risk   2/72 (2.78%)   0/87 (0.00%)   0/81 (0.00%) 
# events   2   0   0 
Schizophrenia †       
# participants affected / at risk   1/72 (1.39%)   0/87 (0.00%)   0/81 (0.00%) 
# events   1   0   0 
Sexually inappropriate behavior †       
# participants affected / at risk   0/72 (0.00%)   1/87 (1.15%)   0/81 (0.00%) 
# events   0   1   0 
† Events were collected by systematic assessment




  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
No text entered.


  More Information