Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia
ANCHOR 112
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)
1 other identifier
interventional
249
10 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Sep 2004
Typical duration for phase_3 schizophrenia
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 30, 2004
CompletedStudy Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 4, 2013
January 1, 2013
August 25, 2004
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (42)
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
Related Publications (1)
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.
PMID: 23083020DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 30, 2004
Study Start
September 1, 2004
Study Completion
June 1, 2007
Last Updated
January 4, 2013
Record last verified: 2013-01