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Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia (ANCHOR 112)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090324
Recruitment Status : Completed
First Posted : August 30, 2004
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: quetiapine fumarate tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)
Study Start Date : September 2004
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42

Secondary Outcome Measures :
  1. Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090324


Locations
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United States, Alabama
Research Site
Dothan, Alabama, United States
United States, California
Research Site
Cerritos, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Florida
Research Site
Alamonte, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
Research Site
Oak Brook, Illinois, United States
United States, Kansas
Research Site
Newton, Kansas, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Nevada
Research Site
Las Vegas, Nevada, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Lyndhurst, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
Research Site
Virginia Beach, Virginia, United States
United States, Washington
Research Site
Kirkland, Washington, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States
Germany
Research Site
Aachen, Germany
India
Research Site
Kanpur, India
Research Site
Lucknow, India
Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Petaling Jaya, Malaysia
Philippines
Research Site
Davao City, Philippines
Research Site
Mandaluyong City, Philippines
Research Site
Manila, Philippines
Research Site
Quezon City, Philippines
Poland
Research Site
Poznan, Poland
Research Site
Torun, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Serbia
Research Site
Belgrade, Serbia
Research Site
Novi Sad, Serbia
South Africa
Research Site
Pretoria, South Africa
Ukraine
Research Site
Kharkov, Ukraine
Research Site
Kiev, Ukraine
Research Site
Odessa, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Seroquel Medical Science Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00090324    
Other Study ID Numbers: D1441C00112
First Posted: August 30, 2004    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs