Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00227305

Purpose

The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

Condition	Intervention	Phase
Schizophrenia Bipolar I Disorder	Drug: quetiapine fumarate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 26-Week, Multicenter, Open-Label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-Release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assess the incidence and nature of overall adverse events (AEs), the rate of patient withdrawal due to AEs, the changes in clinical laboratory test results, SARS, BARS and AIM scores [ Time Frame: OL baseline to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Tanner Stage, changes in menses for female patients, changes in weight and body mass index (BMI); Childrens Global Assessment Scale [ Time Frame: OL baseline to Week 26 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2004
Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Oral dosing, flexible dosing

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 are/is able to provide written informed consent before beginning any study related procedures
Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
Patient's parent or legal guardian will be able to accompany the patient to 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: NCT00227305

Show 46 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1441C00150
Study First Received:	September 27, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00227305 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Schizophrenia
Bipolar I Disorder

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010