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

September 27, 2005
January 3, 2013
August 2004
December 2007   (final data collection date for primary outcome measure)
  • 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  • Number of Patients Withdrawn Due to AEs.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)
Assess the incidence and nature of overall adverse events (AEs), the rate of patient withdrawal due to AEs, the changes in clinical laboratory test results, SARS, BARS & AIM scores
Complete list of historical versions of study NCT00227305 on ClinicalTrials.gov Archive Site
  • 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).
Change from OL baseline to Wk 26 on Tanner Stage, changes in menses for female patients,changes in weight & BMI; Childrens Global Assessment Scale
Not Provided
Not Provided
 
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
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)

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Bipolar I Disorder
Drug: quetiapine fumarate
Oral dosing, flexible dosing
Other Name: Seroquel
Not Provided
Findling RL, Pathak S, Earley WR, Liu S, DelBello M. Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 10.1089/cap.2012.0092. Epub 2013 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Malaysia,   Philippines,   Poland,   Russian Federation,   Serbia,   South Africa,   Ukraine
 
NCT00227305
D1441C00150
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP