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Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT00090311•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

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)

Research Site

Scottsdale, Arizona, United States

Research Site

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

Key Dates

Start Date

July 1, 2004

Completion Date

July 1, 2006

Last Updated

January 4, 2013

Enrollment

220

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

quetiapine fumarate

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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