Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder (ANCHOR 150)
|Study Design:||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)|
- 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.
- Number of Patients Withdrawn Due to AEs.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.
- 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.
- 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.
- 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.
- Change From Baseline in Weight [ Time Frame: 26 weeks of treatment ]Number with 7% or more increase (without adjustment for normal growth)
- Change From Baseline in Supine Pulse [ Time Frame: OL baseline to week 26 ]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 ]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 ]Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
- 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.
- 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).
|Study Start Date:||August 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: quetiapine fumarate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227305
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|Study Director:||Seroquel Medical Science Director, MD||AstraZeneca|