Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

Condition(s) targeted: Bipolar 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 efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Official title: A 3-wk, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-Release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21

Secondary outcome: Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, evaluate safety and tolerability

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 is able to provide written informed consent before beginning and study related procedures

- Patient has a documented clinical diagnosis of Bipolar I mania

- Patient's parent or legal guardian will be able to accompany the patient at 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, Scottsdale, Arizona, United States

Research Site, Sacramento, California, United States

Research Site, San Diego, California, United States

Research Site, Riverside, California, United States

Research Site, Denver, Colorado, United States

Research Site, Alamonte, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Augusta, Georgia, United States

Research Site, Chicago, Illinois, United States

Research Site, Wichita, Kansas, United States

Research Site, New Orleans, Louisiana, United States

Research Site, St. Charles, Missouri, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Clementon, New Jersey, United States

Research Site, Piscataway, New Jersey, United States

Research Site, Rochester, New York, United States

Research Site, Chapel Hill, North Carolina, 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, Madison, 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, Bellevue, Washington, United States

Research Site, Kirkland, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: July 2004
Ending date: January 2007
Last updated: November 2, 2007