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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00090311

Purpose

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

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	220
Study Start Date:	July 2004
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090311

Show 32 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

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

Keywords provided by AstraZeneca:

Bipolar I Mania

Study placed in the following topic categories:

Quetiapine
Affective Disorders, Psychotic
Mental Disorders

Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009