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

Bipolar Disorder Clinical Trial

— ANCHOR 149  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090311
• Other study ID #: D1441C00149
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2004
• Last updated: January 3, 2013
• Start date: July 2004
• Est. completion date: July 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• quetiapine fumarate

Locations

Country	Name	City	State
United States	Research Site	Alamonte	Florida
United States	Research Site	Augusta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clementon	New Jersey
United States	Research Site	Cleveland	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lyndhurst	Ohio
United States	Research Site	Madison	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Piscataway	New Jersey
United States	Research Site	Richmond	Virginia
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	St. Charles	Missouri
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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