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

Condition(s) targeted: Schizophrenia; Bipolar I Disorder

Intervention: quetiapine fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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: 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)

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

Primary outcome: 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

Secondary outcome: Change in Tanner Stage, changes in menses for female patients, changes in weight and body mass index (BMI); Childrens Global Assessment Scale

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Research Site, LUCKNOW, India

Research Site, KUALA LUMPUR, Malaysia

Research Site, PETALING JAYA, Malaysia

Research Site, DAVAO CITY, Philippines

Research Site, MANDALUYONG CITY, Philippines

Research Site, MANILA, Philippines

Research Site, QUEZON CITY, Philippines

Research Site, POZNAN, Poland

Research Site, TORUN, Poland

Research Site, MOSCOW, Russian Federation

Research Site, ST. PETERSBURG, Russian Federation

Research Site, BELGRADE, Serbia and Montenegro

Research Site, NOVI SAD, Serbia and Montenegro

Research Site, PRETORIA, South Africa

Research Site, KHARKOV, Ukraine

Research Site, LVIV, Ukraine

Research Site, ODESSA, Ukraine

Research Site, Dothan, Alabama, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Riverside, California, United States

Research Site, Sacramento, California, United States

Research Site, San Diego, California, United States

Research Site, Cerritos, 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

Research Site, Chicago, Illinois, United States

Research Site, Oak Brook, Illinois, United States

Research Site, Newton, Kansas, United States

Research Site, Overland Park, Kansas, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Rochester, New York, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Cleveland, Ohio, United States

Research Site, Lyndhurst, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Houston, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Richmond, Virginia, United States

Research Site, Virginia Beach, Virginia, United States

Research Site, Kirkland, Washington, United States

Research Site, Bellevue, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: July 2004
Ending date: February 2008
Last updated: February 20, 2008