Phase 3 /Seroquel SR Acute Mania Monotherapy - US - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00422123

Purpose

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition	Intervention	Phase
Affective Psychosis, Bipolar Manic Disorder Manic-Depressive Psychosis Mania Manic State Psychoses, Manic-Depressive	Drug: Quetiapine fumarate (Seroquel) SR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression Psychotic Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from baseline to final visit in the YMRS total score

Secondary Outcome Measures:

Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Enrollment:	447
Study Start Date:	January 2007
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria:

>8 mood episodes within the last 12 months
Use of prohibited medication
Substance or alcohol abuse or dependence
Current suicide risk or suicide attempt within last 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422123

Show 51 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Catherine Datto, MD	AstraZeneca
Study Director:	Larisa Acevedo, Ph.D	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D144CC00004
Study First Received:	January 12, 2007
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00422123 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar Disorder
Bipolar Mania
Manic Depression

Seroquel
Seroquel SR
quetiapine fumarate

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents
Pharmacologic Actions

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

ClinicalTrials.gov processed this record on February 08, 2010