Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia

NCT ID: NCT00090324

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

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-06-30

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 adolescent patients with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

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 tablets

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 schizophrenia
* 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

13 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

Dothan, Alabama, 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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Alamonte, 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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New Orleans, Louisiana, United States

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Las Vegas, Nevada, 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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Memphis, Tennessee, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Kirkland, Washington, United States

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Milwaukee, Wisconsin, United States

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Aachen, , Germany

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Kanpur, , India

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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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Kiev, , Ukraine

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Odesa, , Ukraine

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Countries

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United States Germany India Malaysia Philippines Poland Russia Serbia South Africa Ukraine

References

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Findling RL, McKenna K, Earley WR, Stankowski J, Pathak S. Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2012 Oct;22(5):327-42. doi: 10.1089/cap.2011.0092.

Reference Type DERIVED
PMID: 23083020 (View on PubMed)

Other Identifiers

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D1441C00112

Identifier Type: -

Identifier Source: org_study_id

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