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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Schizophrenia, Bipolar I Disorder

Intervention / Treatment
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* Drug: quetiapine fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: quetiapine fumarate|Oral dosing, flexible dosing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 26 weeks of treatment | 
| Change From Baseline in Weight | Number with 7% or more increase (without adjustment for normal growth) | 26 weeks of treatment | 
| Change From Baseline in Supine Pulse | Change from OL baseline to week 26 in supine pulse (bpm) | 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) | 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) | OL baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | OL Baseline to Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Bipolar I Disorder