Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder (ANCHOR 150)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00227305
First received: September 27, 2005
Last updated: January 3, 2013
Last verified: January 2013
Results First Received: December 22, 2008  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Bipolar I Disorder
Intervention: Drug: quetiapine fumarate

  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
Enrollment was contingent on completing one of 2 short term efficacy studies, recruitment period August 2004 through July 2007 at 59 international clinical research sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Required to have completed one feeder study, either bipolar mania study D1441C00149 or schizophrenia study D1441C00112 and be willing to participate in a 26 week open label study and be between the ages of 10 and 18 years at the time of consent for this study, initial titration to maintain blind in feeder study

Reporting Groups
  Description
Quetiapine Quetiapine 400mg/day to 800mg/day

Participant Flow:   Overall Study
    Quetiapine  
STARTED     381 [1]
Drug Received     380 [2]
COMPLETED     237 [3]
NOT COMPLETED     144  
Adverse Event                 40  
Withdrawal by Subject                 42  
Lost to Follow-up                 33  
Study specific discontinuation                 13  
MOVED OUT OF AREA                 3  
Lack of Efficacy                 7  
Physician Decision                 3  
PERIOD SHORTENED FROM 6 wks to 4 wks                 1  
LEAVING TOWN FOR 6 WEEKS                 1  
NECESSITY OF USING ANTI DEPRESSANT                 1  
[1] enrolled
[2] safety population
[3] Completed 26 weeks



  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
Quetiapine Quetiapine 400mg/day to 800mg/day

Baseline Measures
    Quetiapine  
Number of Participants  
[units: participants]
  380  
Age, Customized  
[units: Participants]
 
10 - 12 years     87  
13 - 18 years     293  
Gender  
[units: Participants]
 
Female     154  
Male     226  
Diagnosis  
[units: participantĀ fromĀ feederĀ studies]
 
Bipolar     205  
Schizophrenia     175  



  Outcome Measures
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1.  Primary:   Incidence and Nature of Adverse Events (AEs)   [ Time Frame: from open label to week 26+ 30 days ]

2.  Primary:   Number of Patients Withdrawn Due to AEs.   [ Time Frame: during 26 weeks of treatment ]

3.  Primary:   Changes in Laboratory Test Results (Prolactin)   [ Time Frame: Duration of study participation ]

4.  Primary:   Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score   [ Time Frame: OL baseline to week 26 ]

5.  Primary:   Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score   [ Time Frame: 26 weeks of treatment ]

6.  Primary:   Change From Baseline in Weight   [ Time Frame: 26 weeks of treatment ]

7.  Primary:   Change From Baseline in Supine Pulse   [ Time Frame: OL baseline to week 26 ]

8.  Primary:   Change From OL Baseline in Supine Systolic BP.   [ Time Frame: OL baseline to Week 26 ]

9.  Primary:   Change From OL Baseline in Supine Diastolic BP.   [ Time Frame: OL baseline to Week 26 ]

10.  Secondary:   Changes in Tanner Stage   [ Time Frame: Change from OL baseline to week 26 in the Tanner stage ]

11.  Secondary:   Change From Baseline in Children's Global Assessment Scale (CGAS) Score   [ Time Frame: OL Baseline to Week 26 ]


  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
No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development


  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: Seroquel Medical Science Director, MD
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00227305     History of Changes
Other Study ID Numbers: D1441C00150
Study First Received: September 27, 2005
Results First Received: December 22, 2008
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration