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
  Purpose

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 Intervention Phase
Schizophrenia
Bipolar I Disorder
Drug: quetiapine fumarate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

  • Number of Patients Withdrawn Due to AEs. [ Time Frame: during 26 weeks of treatment ] [ Designated as safety issue: Yes ]
    Number of subjects who withdrew from the study due to AEs.

  • Changes in Laboratory Test Results (Prolactin) [ Time Frame: Duration of study participation ] [ Designated as safety issue: Yes ]

    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.


  • Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score [ Time Frame: OL baseline to week 26 ] [ Designated as safety issue: Yes ]

    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.


  • Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score [ Time Frame: 26 weeks of treatment ] [ Designated as safety issue: Yes ]

    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.


  • Change From Baseline in Weight [ Time Frame: 26 weeks of treatment ] [ Designated as safety issue: Yes ]
    Number with 7% or more increase (without adjustment for normal growth)

  • Change From Baseline in Supine Pulse [ Time Frame: OL baseline to week 26 ] [ Designated as safety issue: Yes ]
    Change from OL baseline to week 26 in supine pulse (bpm)

  • Change From OL Baseline in Supine Systolic BP. [ Time Frame: OL baseline to Week 26 ] [ Designated as safety issue: Yes ]
    Changes from OL baseline to the final visits in Supine systolic BP (mmHg)

  • Change From OL Baseline in Supine Diastolic BP. [ Time Frame: OL baseline to Week 26 ] [ Designated as safety issue: Yes ]
    Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)


Secondary Outcome Measures:
  • Changes in Tanner Stage [ Time Frame: Change from OL baseline to week 26 in the Tanner stage ] [ Designated as safety issue: Yes ]

    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.


  • Change From Baseline in Children's Global Assessment Scale (CGAS) Score [ Time Frame: OL Baseline to Week 26 ] [ Designated as safety issue: No ]
    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).


Enrollment: 381
Study Start Date: August 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: quetiapine fumarate
    Oral dosing, flexible dosing
    Other Name: Seroquel
  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227305

  Show 48 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by AstraZeneca:
Schizophrenia
Bipolar I Disorder

Additional relevant MeSH terms:
Schizophrenia
Disease
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014