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Seroquel XR in Adults With Schizophrenia

This study has been terminated.
(The study was prematurely terminated due to insufficient recruitment.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00852631
First received: February 26, 2009
Last updated: June 12, 2012
Last verified: May 2012
Results First Received: May 18, 2011  
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 (Seroquel)

  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
Patients provide informed consent and are screened for eligibility (at Visit 1) up to 7 days before baseline assessment on Day 1.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.

Reporting Groups
  Description
Seroquel XR Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Participant Flow:   Overall Study
    Seroquel XR  
STARTED     28  
COMPLETED     17  
NOT COMPLETED     11  



  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.
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Reporting Groups
  Description
Seroquel XR Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Baseline Measures
    Seroquel XR  
Number of Participants  
[units: participants]
  28  
Age  
[units: Years]
Median ± Standard Deviation
  43  ± 39.5  
Gender  
[units: participants]
 
Female     8  
Male     20  



  Outcome Measures
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1.  Primary:   Change in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: From Day 1 (baseline) to Day 42 ]

2.  Secondary:   Change in Clinical Global Impression - Severity of Illness (CGI-S) Score   [ Time Frame: From Day 1 (Baseline) to Day 42 ]

3.  Secondary:   Clinical Global Impression - Severity of Illness (CGI-S) Score   [ Time Frame: Day 14 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: clinicaltrialtransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00852631     History of Changes
Other Study ID Numbers: D1443L00060
Study First Received: February 26, 2009
Results First Received: May 18, 2011
Last Updated: June 12, 2012
Health Authority: Thailand: Ethical Committee