Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders (OPAL)

March 24, 2009 updated by: AstraZeneca

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • El Centro, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • National City, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States
        • Research Site
    • Delaware
      • Wilmington, Delaware, United States
        • Research Site
    • Florida
      • Altamonte Springs, Florida, United States
        • Research Site
      • DeLand, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • New Port Richey, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Roswell, Georgia, United States
        • Research Site
    • Illinois
      • Naperville, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
      • Lafayette, Indiana, United States
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Massachusetts
      • Braintree, Massachusetts, United States
        • Research Site
      • Cambridge, Massachusetts, United States
        • Research Site
      • Pittsfield, Massachusetts, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New York
      • Staten Island, New York, United States
        • Research Site
    • Ohio
      • Avon Lake, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • DeSoto, Texas, United States
        • Research Site
      • Houston, Texas, 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:

  • 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 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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score

Secondary Outcome Measures

Outcome Measure
To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo

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

April 1, 2006

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (ESTIMATE)

May 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1448C00003
  • Opal

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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