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
  Hide 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
  Hide 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  
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
  Show All 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


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Medical Director, CNS
Organization: Sunovion Pharmaceuticals
phone: 1-866-503-6351


Publications of Results:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143077     History of Changes
Other Study ID Numbers: D1050289
Study First Received: June 10, 2010
Results First Received: May 15, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration