A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01143090
First received: June 10, 2010
Last updated: January 3, 2013
Last verified: January 2013
Results First Received: November 15, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group 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 August 10, 2010-LPV November 28, 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
Open Label Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.

Participant Flow:   Overall Study
    Open Label  
STARTED     149  
COMPLETED     98  
NOT COMPLETED     51  
Lack of Efficacy                 2  
Adverse Event                 17  
Lost to Follow-up                 9  
Protocol Violation                 2  
Withdrawal by Subject                 18  
Non-compliance with study drug                 1  
Failure to meet eligibility criteria                 1  
Administrative                 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
Open Label Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.

Baseline Measures
    Open Label  
Number of Participants  
[units: participants]
  148  
Age  
[units: participants]
 
<=18 years     2  
Between 18 and 65 years     146  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.8  ± 11.1  
Gender  
[units: participants]
 
Female     55  
Male     93  
Region of Enrollment [1]
[units: participants]
 
United States     148  
[1] One enrolled subject did not receive any study medication and was excluded from this summary.



  Outcome Measures

1.  Primary:   Adverse Events   [ Time Frame: 6 months ]

2.  Secondary:   Efficacy   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  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.


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


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01143090     History of Changes
Other Study ID Numbers: D1050290
Study First Received: June 10, 2010
Results First Received: November 15, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration