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)”

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

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: quetiapine fumarate
  • Oral dosing, flexible dosing

Primary Measures

• 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 and AIM scores
  • Time Frame: OL baseline to Week 26
    Safety Issue?: No

Secondary Measures

• Change in Tanner Stage, changes in menses for female patients, changes in weight and body mass index (BMI); Childrens Global Assessment Scale
  • Time Frame: OL baseline to Week 26
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Seroquel Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00227305

Study ID Number: D1441C00150

ClinicalTrials.gov Identifier: NCT00227305

Health Authority: United States: Food and Drug Administration