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

AstraZeneca220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Bipolar Disorder

Interventions

quetiapine fumarateDRUG

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (32)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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