Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

Major Depressive Disorder Clinical Trial

— OPAL  

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326144
• Other study ID #: D1448C00003
• Secondary ID: OPAL
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: March 24, 2009
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient is able to provide written informed consent before beginning any study related procedures

• Patient has a documented clinical diagnosis of major depressive disorder

• Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion Criteria:

• Patients with a history of non-compliance as judged by the study investigator

• Patients with a known lack of response to previous treatment with quetiapine

• Patients who have participated in a clinical trial within 4 weeks of randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Quetiapine fumarate

Locations

Country	Name	City	State
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Altamonte Springs	Florida
United States	Research Site	Anaheim	California
United States	Research Site	Atlanta	Georgia
United States	Research Site	Avon Lake	Ohio
United States	Research Site	Braintree	Massachusetts
United States	Research Site	Cambridge	Massachusetts
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	DeLand	Florida
United States	Research Site	DeSoto	Texas
United States	Research Site	El Centro	California
United States	Research Site	Garden Grove	California
United States	Research Site	Hartford	Connecticut
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lafayette	Indiana
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Naperville	Illinois
United States	Research Site	National City	California
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New Port Richey	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsfield	Massachusetts
United States	Research Site	Riverside	California
United States	Research Site	Roswell	Georgia
United States	Research Site	St. Louis	Missouri
United States	Research SIte	Staten Island	New York
United States	Research Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
Secondary	To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
Secondary	To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo