Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder

NCT ID: NCT00227305

Last Updated: 2013-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

Detailed Description

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Conditions

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Schizophrenia Bipolar I Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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quetiapine fumarate

Oral dosing, flexible dosing

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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Inclusion Criteria

* Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
* Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
* Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
* Patient's parent or legal guardian will be able to accompany the patient to 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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seroquel Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Dothan, Alabama, United States

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Scottsdale, Arizona, United States

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Cerritos, California, United States

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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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Altamonte Springs, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Newton, Kansas, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Las Vegas, Nevada, United States

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Rochester, New York, 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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Memphis, 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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Lucknow, , India

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Kuala Lumpur, , Malaysia

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Petaling Jaya, , Malaysia

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Davao City, , Philippines

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Mandaluyong, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Poznan, , Poland

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Torun, , Poland

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Moscow, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Novi Sad, , Serbia

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Pretoria, , South Africa

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Kharkiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Countries

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United States India Malaysia Philippines Poland Russia Serbia South Africa Ukraine

References

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Findling RL, Pathak S, Earley WR, Liu S, DelBello M. Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 10.1089/cap.2012.0092. Epub 2013 Sep 11.

Reference Type DERIVED
PMID: 24024534 (View on PubMed)

Other Identifiers

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D1441C00150

Identifier Type: -

Identifier Source: org_study_id

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