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

Major Depressive Disorder Clinical Trial

— DIAMOND  

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-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: NCT00321490
• Other study ID #: D1448C00002
• Secondary ID: Diamond
• 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

• Duloxetine

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boca Raton	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Columbia	South Carolina
United States	Research Site	Dayton	Ohio
United States	Research Site	Edwardsville	Illinois
United States	Research Site	Haverhill	Massachusetts
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Mayfield Village	Ohio
United States	Research Site	Memphis	Tennessee
United States	Research Site	Morgantown	West Virginia
United States	Research Site	New York City	New York
United States	Research Site	Okemos	Michigan
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Princeton	New Jersey
United States	Research Site	Richmond	Virginia
United States	Research Site	Salem	Oregon
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Sherman Oaks	California
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Paul	Minnesota
United States	Research Site	Tampa	Florida
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wildomar	California

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