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

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ClinicalTrials.gov Identifier: NCT00227305
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : October 5, 2012
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar I Disorder Drug: quetiapine fumarate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)
Study Start Date : August 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Intervention Details:
  • Drug: quetiapine fumarate
    Oral dosing, flexible dosing
    Other Name: Seroquel

Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Nature of Adverse Events (AEs) [ Time Frame: from open label to week 26+ 30 days ]
    Number of participants that had AE which occurred from first dose date to last dose date + 30 days.

  2. Number of Patients Withdrawn Due to AEs. [ Time Frame: during 26 weeks of treatment ]
    Number of subjects who withdrew from the study due to AEs.

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

    Clinical important shift to high prolactin from open-label (OL) baseline to week 26.

    High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male.


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

    Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).

    Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score.


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

    Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.

    Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score.


  6. Change From Baseline in Weight [ Time Frame: 26 weeks of treatment ]
    Number with 7% or more increase (without adjustment for normal growth)

  7. Change From Baseline in Supine Pulse [ Time Frame: OL baseline to week 26 ]
    Change from OL baseline to week 26 in supine pulse (bpm)

  8. Change From OL Baseline in Supine Systolic BP. [ Time Frame: OL baseline to Week 26 ]
    Changes from OL baseline to the final visits in Supine systolic BP (mmHg)

  9. Change From OL Baseline in Supine Diastolic BP. [ Time Frame: OL baseline to Week 26 ]
    Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)


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

    Category shift in Tanner stage. Number of subjects who experienced the change is presented.

    Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.


  2. Change From Baseline in Children's Global Assessment Scale (CGAS) Score [ Time Frame: OL Baseline to Week 26 ]
    Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
  • Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
  • Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
  • Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit

Exclusion Criteria:

  • Patients (female) must not be pregnant or lactating
  • Patients with a known intolerance or lack of response to previous treatment with quetiapine
  • Patients who have previously participated in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227305


Locations
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United States, Alabama
Research Site
Dothan, Alabama, United States
United States, Arizona
Research Site
Scottsdale, Arizona, United States
United States, California
Research Site
Cerritos, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Florida
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Altamonte Springs, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
United States, Illinois
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Chicago, Illinois, United States
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Oak Brook, Illinois, United States
United States, Kansas
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Newton, Kansas, United States
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Overland Park, Kansas, United States
United States, Louisiana
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New Orleans, Louisiana, United States
United States, Nevada
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Las Vegas, Nevada, United States
United States, New York
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Rochester, New York, United States
United States, Ohio
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Lyndhurst, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
United States, Tennessee
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Memphis, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
United States, Virginia
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
United States, Washington
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Bellevue, Washington, United States
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Kirkland, Washington, United States
United States, Wisconsin
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Milwaukee, Wisconsin, United States
India
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Lucknow, India
Malaysia
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Kuala Lumpur, Malaysia
Research Site
Petaling Jaya, Malaysia
Philippines
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Davao City, Philippines
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Mandaluyong City, Philippines
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Manila, Philippines
Research Site
Quezon City, Philippines
Poland
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Poznan, Poland
Research Site
Torun, Poland
Russian Federation
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
Serbia
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Belgrade, Serbia
Research Site
Novi Sad, Serbia
South Africa
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Pretoria, South Africa
Ukraine
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Kharkov, Ukraine
Research Site
Lviv, Ukraine
Research Site
Odessa, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Seroquel Medical Science Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00227305    
Other Study ID Numbers: D1441C00150
First Posted: September 28, 2005    Key Record Dates
Results First Posted: October 5, 2012
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Schizophrenia
Bipolar I Disorder
Additional relevant MeSH terms:
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Disease
Schizophrenia
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
 Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs