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

NCT ID: NCT00090311

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-07-31

Brief Summary

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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

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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quetiapine fumarate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Scottsdale, Arizona, United States

Site Status

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Alamonte, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Saint Charles, Missouri, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Piscataway, New Jersey, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Madison, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Pathak S, Findling RL, Earley WR, Acevedo LD, Stankowski J, Delbello MP. Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Jan;74(1):e100-9. doi: 10.4088/JCP.11m07424.

Reference Type DERIVED
PMID: 23419231 (View on PubMed)

Other Identifiers

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D1441C00149

Identifier Type: -

Identifier Source: org_study_id

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