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

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00090311

Run by

AstraZeneca

People needed

220

Starts

2004-07-01

Expected to finish

2006-07-01

Last updated by the study team

2013-01-04

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — 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 — Saint 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

Full record on ClinicalTrials.gov

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