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A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01566162
First received: March 27, 2012
Last updated: November 12, 2014
Last verified: November 2014
Results First Received: October 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Lurasidone

  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
No text entered.

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

Lurasidone 40 – 80mg flexible dose

Lurasidone: Lurasidone 40-80 mg taken orally taken once daily


Participant Flow:   Overall Study
    Lurasidone  
STARTED     191  
COMPLETED     155  
NOT COMPLETED     36  



  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

Lurasidone 40 – 80mg flexible dose

Lurasidone: Lurasidone 40-80 mg taken orally taken once daily


Baseline Measures
    Lurasidone  
Number of Participants  
[units: participants]
  191  
Age  
[units: Years]
Mean ± Standard Deviation
  42.7  ± 12.30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     190  
>=65 years     1  
Gender  
[units: participants]
 
Female     76  
Male     115  
Region of Enrollment  
[units: participants]
 
Serbia     22  
France     4  
United States     114  
Slovakia     15  
Russian Federation     19  
South Africa     17  
Italy     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)   [ Time Frame: 12 weeks ]

2.  Primary:   Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline to week 12 LOCF endpoint ]

3.  Primary:   Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.   [ Time Frame: Baseline to week 12 LOCF endpoint ]

4.  Secondary:   Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score   [ Time Frame: Baseline to week 12 LOCF endpoint ]

5.  Secondary:   Short Form-12 Health Survey (SF-12)   [ Time Frame: Baseline to week 12 LOCF endpoint ]

6.  Secondary:   Modified Specific Levels of Functioning (SLOF) Total Score.   [ Time Frame: 12 weeks ]

7.  Secondary:   Brief Adherence Rating Scale (BARS)   [ Time Frame: 12 weeks ]

8.  Secondary:   Smoking Questionnaire   [ Time Frame: 12 weeks ]

9.  Secondary:   Intent to Attend Assessment   [ Time Frame: 12 weeks ]


  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
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  More Information
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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 Clinical Trials
Organization: Sunovion
phone: 1-866-503-6351
e-mail: clinicaltrialdisclosure@sunvion.com


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01566162     History of Changes
Other Study ID Numbers: D1050307, 2011-004790-90
Study First Received: March 27, 2012
Results First Received: October 21, 2014
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Ukraine: Ministry of Health