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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00090311 |
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.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: quetiapine fumarate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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) |
Enrollment: | 220 |
Study Start Date: | July 2004 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Seroquel Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1441C00149 |
Study First Received: | August 25, 2004 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00090311 |
Health Authority: | United States: Food and Drug Administration |
Bipolar I Mania |
Quetiapine Affective Disorders, Psychotic Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |