Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania
ANCHOR 149
A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)
1 other identifier
interventional
220
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2004
32 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
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
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 bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21
Secondary Outcomes (1)
Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, 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 Bipolar I mania
- 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 (32)
Research Site
Scottsdale, Arizona, 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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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
Related Publications (1)
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.
PMID: 23419231DERIVED
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
July 1, 2004
Study Completion
July 1, 2006
Last Updated
January 4, 2013
Record last verified: 2013-01