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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

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