Phase III/Seroquel SR Bipolar Depression Monotherapy - US - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00422214

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 Depression for 8 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 Depression, Bipolar Manic-Depressive Psychosis 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 SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

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 in depression symptoms by final visit as measured by the MADRS total score

Secondary Outcome Measures:

Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Estimated Enrollment:	400
Study Start Date:	December 2006
Study Completion Date:	June 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 1 disorder or Bipolar 11 disorder
Outpatient status at enrollment

Exclusion Criteria:

Patients with >8 mood episodes during the past 12 years
Use of prohibited medications
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: NCT00422214

Show 54 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:	D144CC00002
Study First Received:	January 12, 2007
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00422214 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar Disorder
Bipolar Depression,
Manic Depression

Seroquel
Seroquel SR
quetiapine fumarate

Additional relevant MeSH terms:

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

Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
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 04, 2010