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Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) (QUENCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00779506
First received: October 22, 2008
Last updated: October 19, 2011
Last verified: May 2010
History of Changes
Results First Received: May 20, 2010  
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: Quetiapine Fumarate XR

  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
From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea

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
Quetiapine XR This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients

Participant Flow:   Overall Study
    Quetiapine XR  
STARTED     96  
Enrolled     96  
Screen Failed     2  
Assigned     94  
MITT     89  
Treatment Complete     67  
Withdrawal Treatment     27  
COMPLETED     67  
NOT COMPLETED     29  
Screening Failed                 2  
Adverse Event                 4  
Lack of Efficacy                 11  
Protocol Violation                 5  
Withdrawal by Subject                 6  
Lost to Follow-up                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Quetiapine XR This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients

Baseline Measures
    Quetiapine XR  
Number of Participants  
[units: participants]
 		  89  
Age  
[units: Years]
Mean ± Standard Deviation 		 
Female     35.8  ± 13  
Male     42.4  ± 9.8  
Total     39.7  ± 11.6  
Gender  
[units: Participants]
 		 
Female     37  
Male     52  
BMI  
[units: kg/m2]
Mean ± Standard Deviation 		 
Female     23.7  ± 5.4  
Male     23.4  ± 3.5  
Total     23.5  ± 4.4  
Height  
[units: cm]
Mean ± Standard Deviation 		 
Female     158  ± 5.9  
Male     168.7  ± 6.6  
Total     164.2  ± 8.2  
Weight  
[units: kg]
Mean ± Standard Deviation 		 
Female     59.1  ± 13  
Male     66.6  ± 11.4  
Total     63.5  ± 12.6  



  Outcome Measures
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1.  Primary:   The Change in Positive and Negative Syndrome Scale(PANSS)Total Score   [ Time Frame: From baseline to Day 57 ]
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2.  Secondary:   Positive and Negative Syndrome Scale (PANSS) Positive Score   [ Time Frame: From baseline to Day 57 ]
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3.  Secondary:   Positive and Negative Syndrome Scale (PANSS) Negative Score   [ Time Frame: From baseline to Day 57 ]
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4.  Secondary:   Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score   [ Time Frame: From baseline to Day 57 ]
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5.  Secondary:   Clinical Global Impression (CGI) Score   [ Time Frame: From baseline to Day 57 ]
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6.  Secondary:   Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: From baseline to Day 57 ]
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7.  Secondary:   Global Assessment of Functioning (GAF) Score   [ Time Frame: From baseline to Day 57 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00779506     History of Changes
Other Study ID Numbers: D1443L00062
Study First Received: October 22, 2008
Results First Received: May 20, 2010
Last Updated: October 19, 2011
Health Authority: Korea: Food and Drug Administration