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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
381
Oral dosing, flexible dosing
Incidence and Nature of Adverse Events (AEs)
Number of participants that had AE which occurred from first dose date to last dose date + 30 days.
Time frame: from open label to week 26+ 30 days
Number of Patients Withdrawn Due to AEs.
Number of subjects who withdrew from the study due to AEs.
Time frame: during 26 weeks of treatment
Changes in Laboratory Test Results (Prolactin)
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.
Time frame: Duration of study participation
Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
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.
Time frame: OL baseline to week 26
Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
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.
Time frame: 26 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Dothan, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Cerritos, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Denver, Colorado, United States
Research Site
Altamonte Springs, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
...and 38 more locations
Change From Baseline in Weight
Number with 7% or more increase (without adjustment for normal growth)
Time frame: 26 weeks of treatment
Change From Baseline in Supine Pulse
Change from OL baseline to week 26 in supine pulse (bpm)
Time frame: OL baseline to week 26
Change From OL Baseline in Supine Systolic BP.
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
Time frame: OL baseline to Week 26
Change From OL Baseline in Supine Diastolic BP.
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
Time frame: OL baseline to Week 26
Changes in 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.
Time frame: Change from OL baseline to week 26 in the Tanner stage
Change From Baseline in Children's Global Assessment Scale (CGAS) Score
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).
Time frame: OL Baseline to Week 26