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Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Primary Purpose

Affective Psychosis, Bipolar, Manic Disorder, 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 Mania, 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 Disorder, with most recent episode being manic or mixed
  • Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria:

  • >8 mood episodes within the last 12 months
  • Use of prohibited medication
  • 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 to final visit in the YMRS total score

Secondary Outcome Measures

Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

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
NCT00422123
Brief Title
Phase 3 /Seroquel SR Acute Mania 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®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 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 Mania for 3 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, Manic Disorder, Manic-Depressive Psychosis, Mania, Manic State, Psychoses, Manic-Depressive
Keywords
Bipolar Disorder, Bipolar Mania, 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
447 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate (Seroquel) SR
Primary Outcome Measure Information:
Title
Change from baseline to final visit in the YMRS total score
Secondary Outcome Measure Information:
Title
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

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 Disorder, with most recent episode being manic or mixed Inpatient hospital admission for the first 4 days of study treatment Exclusion Criteria: >8 mood episodes within the last 12 months Use of prohibited medication 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
Phoenix
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
Garden Grove
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
Santa Ana
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Site
City
East Bradenton
State/Province
Florida
Country
United States
Facility Name
Research Sitew
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Leesburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Research Site
City
Hoffman Estates
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Naperville
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oak Brook Terrace
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
Newton
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
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
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Kenilworth
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Willingboro
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Elmsford
State/Province
New York
Country
United States
Facility Name
Research Site
City
Holliswood
State/Province
New York
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Moon Township
State/Province
Pennsylvania
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
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Desoto
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22054797
Citation
Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.
Results Reference
derived

Learn more about this trial

Phase 3 /Seroquel SR Acute Mania Monotherapy - US

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