Seroquel in Bipolar Depression Versus SSRI (EMBOLDEN II)

January 3, 2013 updated by: AstraZeneca

Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

676

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Research Site
      • Everton Park, Queensland, Australia
        • Research Site
      • Southport, Queensland, Australia
        • Research Site
    • Victoria
      • Epping, Victoria, Australia
        • Research Site
      • Malvern, Victoria, Australia
        • Research Site
  • Chile
      • Providencia Santiago, Chile
        • Research Site
      • Santiago, Chile
        • Research Site
  • Colombia
      • Bogota, Colombia
        • Research Site
  • Costa Rica
      • San Jose, Costa Rica
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Tripoli, Greece
        • Research Site
  • Mexico
      • Mexico, Mexico
        • Research Site
      • Yucatan, Mexico
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
      • San Borja, Peru
        • Research Site
  • Romania
      • Bucharest, Romania
        • Research Site
      • Galati, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Magura, Romania
        • Research Site
  • South Africa
      • Benoni, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
  • Turkey
      • Gaziantep, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Manisa, Turkey
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • National City, California, United States
        • Research Site
      • San Clemente, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Florida
      • Maitland, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Smyrna, Georgia, United States
        • Research Site
    • Illinois
      • Northfield, Illinois, United States
        • Research Site
      • Oak Brook, Illinois, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Clementon, New Jersey, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Kirkland, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female out-patients aged 18 to 65 years inclusive
  • Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion Criteria:

  • Current period of depression lasting less than 4 weeks or more than 12 months
  • Use of prohibited medication
  • Substance or alcohol dependence or abuse
  • Current suicide risk or suicide attempt within 6 months
  • Breast feeding or pregnancy
  • Clinically relevant disease or clinical finding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Outcome Measure
Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 6, 2005

First Submitted That Met QC Criteria

July 13, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1447C00134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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