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
Conditions
Bipolar Disorder
Study Type
Interventional
Study Design
Treatment, Placebo Control, Safety/Efficacy Study
Further Details
Study Start
Eligibility & 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
Total Enrolment
Contact Details
AstraZeneca Information Center (8 AM – 7 PM EST) 1-800-236-9933
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