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

Major Depressive Disorder Clinical Trial

— PEARL  

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 SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment (PEARL STUDY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326105
• Other study ID #: D1448C00006
• Secondary ID: PEARL
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: March 24, 2009
• Start date: April 2006
• Est. completion date: July 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 evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.

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: 450
• Est. completion date: July 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, 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	Arlington	Virginia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Beechwood	Ohio
United States	Research Site	Bellevue	Washington
United States	Research Site	Braintree	Massachusetts
United States	Research Site	Cedarhurst	New York
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Clementon	New Jersey
United States	Research Site	Clinton Township	Michigan
United States	Research Site	Columbia	South Carolina
United States	Research Site	Coral Springs	Florida
United States	Research Site	Deland	Florida
United States	Research Site	El Centro	California
United States	Research Site	Friendswood	Texas
United States	Research Site	Gainsville	Florida
United States	Research SIte	Glen Burnie	Maryland
United States	Research Site	Hialeah	Florida
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irvine	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Lafayette	Indiana
United States	Research Site	Lincoln	Rhode Island
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Naperville	Illinois
United States	Research Site	New York	New York
United States	Research Site	Norman	Oklahoma
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olean	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Pueblo	Colorado
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Roswell	Georgia
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Springfield	Massachusetts
United States	Research Site	St Charles	Missouri
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Toledo	Ohio
United States	Research Site	Valparaiso	Indiana
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research SIte	Wichita Falls	Texas

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 in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
Secondary	To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone
Secondary	To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone