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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 children and adolescent patients with Bipolar I mania.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23419231 | Derived | 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. |
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| Riverside |
| California |
| United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Alamonte | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Saint Charles | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Piscataway | New Jersey | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Lyndhurst | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Madison | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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