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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00090311

Public ClinicalTrials.gov record NCT00090311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 6:55 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00090311
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
220 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2004 (Type not available)
Primary completion
Not listed
Completion
Jul 2006 (Actual)
Last update posted
Jan 4, 2013

2004 – 2006

United States locations

U.S. sites
32
U.S. states
21
U.S. cities
32
Facility City State ZIP Site status
Research Site Scottsdale Arizona — —
Research Site Riverside California — —
Research Site Sacramento California — —
Research Site San Diego California — —
Research Site Denver Colorado — —
Research Site Alamonte Florida — —
Research Site Jacksonville Florida — —
Research Site Miami Florida — —
Research Site Augusta Georgia — —
Research Site Chicago Illinois — —
Research Site Wichita Kansas — —
Research Site New Orleans Louisiana — —
Research Site Saint Charles Missouri — —
Research Site Las Vegas Nevada — —
Research Site Clementon New Jersey — —
Research Site Piscataway New Jersey — —
Research Site Rochester New York — —
Research Site Chapel Hill North Carolina — —
Research Site Cincinnati Ohio — —
Research Site Cleveland Ohio — —
Research Site Lyndhurst Ohio — —
Research Site Oklahoma City Oklahoma — —
Research Site Philadelphia Pennsylvania — —
Research Site Madison Tennessee — —
Research Site Austin Texas — —
Research Site Houston Texas — —
Research Site San Antonio Texas — —
Research Site Richmond Virginia — —
Research Site Virginia Beach Virginia — —
Research Site Bellevue Washington — —
Research Site Kirkland Washington — —
Research Site Milwaukee Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00090311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 4, 2013 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00090311 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →