drugset / Trial / NCT00090311

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

NCT00090311

Phase 3 Completed 220 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-07
Primary completion
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule 400 mg
Subject Quetiapine Small molecule 600 mg

Indications