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

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00090311
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-08-25
• Study First Submitted QC: 2004-08-27
• Study First Posted: 2004-08-30
• Study Completion: 2006-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States