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Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Primary Purpose

Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine fumarate (Seroquel) SR
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Affective Psychosis, Bipolar focused on measuring Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Outcomes

Primary Outcome Measures

Change from baseline in depression symptoms by final visit as measured by the MADRS total score

Secondary Outcome Measures

Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Full Information

First Posted
January 12, 2007
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00422214
Brief Title
Phase III/Seroquel SR Bipolar Depression Monotherapy - US
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive
Keywords
Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate (Seroquel) SR
Primary Outcome Measure Information:
Title
Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Secondary Outcome Measure Information:
Title
Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Datto, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Larisa Acevedo, Ph.D
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Northridge
State/Province
California
Country
United States
Facility Name
Research Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
Research Site
City
Pico Rivera
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Wildomar
State/Province
California
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Leesburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Smyrna
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Research Site
City
Joliet
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Greenwood
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Research Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Salem
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
South Kirkland
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Phase III/Seroquel SR Bipolar Depression Monotherapy - US

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