Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— MOONSTONE  

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®) as Monotherapy in the Treatment of Patients With MDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320268
• Other study ID #: D1448C00001
• Secondary ID: Moonstone
• Status: Completed
• Phase: Phase 3
• First received: May 1, 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

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient has a documented clinical diagnosis of Major Depressive Disorder.

• Be able to understand and comply with the requirements of the study.

• Able to understand and provide written informed consent

Exclusion Criteria:

• Patients (female) must not be pregnant or lactating

• Current or past diagnosis of stroke or transient ischemic attack (TIA).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Brooklyn	New York
United States	Research Site	Brown Deer	Wisconsin
United States	Research Site	Charleston	West Virginia
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clementon	New Jersey
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Eagle	Idaho
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Jacksonville	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Memphis	Tennessee
United States	Research Site	New York City	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Norristown	Pennsylvania
United States	Research Site	Northridge	California
United States	Research Site	Norwich	Connecticut
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Oceanside	California
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Ana	California
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Georgia
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wichita	Kansas
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary	Change from randomization to each assessment in the MADRS total score
Secondary	MADRS response, defined as a =50% reduction from randomization in the MADRS total score at Week 6