Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Depression, Bipolar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422214
• Other study ID #: D144CC00002
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2007
• Last updated: March 24, 2009
• Start date: December 2006
• Est. completion date: June 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Affective Disorders, Psychotic
• Affective Psychosis, Bipolar
• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder
• Manic-Depressive Psychosis
• Mental Disorders
• Psychoses, Manic-Depressive
• Psychotic Disorders

Intervention

Drug:
• Quetiapine fumarate (Seroquel) SR

Locations

Country	Name	City	State
United States	Research Site	Beachwood	Ohio
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bradenton	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Cerritos	California
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlottesville	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	Dayton	Ohio
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Greenwood	Indiana
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Joliet	Illinois
United States	Research Site	La Mesa	California
United States	Research Site	Leesburg	Florida
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	North Miami	Florida
United States	Research Site	Northridge	California
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pico Rivera	California
United States	Research Site	Portland	Oregon
United States	Research Site	Rockville	Maryland
United States	Research Site	Salem	Oregon
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Georgia
United States	Research Site	South Kirkland	Washington
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Tampa	Florida
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Washington	District of Columbia
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
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 baseline in depression symptoms by final visit as measured by the MADRS total score
Secondary	Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C