Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (ONYX)

January 25, 2011 updated by: AstraZeneca

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

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

Major Depressive Disorder

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

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
- - Brisbane, Australia
    - Research Site
- Queensland
  - Everton Park, Queensland, Australia
    - Research Site
  - Southport, Queensland, Australia
    - Research Site
- Victoria
  - Frankston, Victoria, Australia
    - Research Site
  - Malvern, Victoria, Australia
    - Research Site
  - Prahran, Victoria, Australia
    - Research Site
  - Richmond, Victoria, Australia
    - Research Site
Belgium
- - Assebroek, Belgium
    - Research Site
  - Brussels, Belgium
    - Research Site
  - Gent, Belgium
    - Research Site
  - Kortrijk, Belgium
    - Research Site
  - Liege, Belgium
    - Research Site
  - Mechelen, Belgium
    - Research Site
  - Tielt, Belgium
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada
    - Research Site
- New Brunswick
  - Moncton, New Brunswick, Canada
    - Research Site
- Newfoundland and Labrador
  - Mount Pearl, Newfoundland and Labrador, Canada
    - Research Site
  - St. John's, Newfoundland and Labrador, Canada
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada
    - Research Site
- Ontario
  - Toronto, Ontario, Canada
    - Research Site
- Quebec
  - Pointe-claire, Quebec, Canada
    - Research Site
Czech Republic
- - Brno, Czech Republic
    - Research Site
  - Havirov, Czech Republic
    - Research Site
  - Havlickuv Brod, Czech Republic
    - Research Site
  - Nove Mesto nad Metuji, Czech Republic
    - Research Site
  - Olomouc, Czech Republic
    - Research Site
  - Ostrava, Czech Republic
    - Research Site
  - Praha 10, Czech Republic
    - Research Site
  - Praha 5, Czech Republic
    - Research Site
  - Praha 8, Czech Republic
    - Research Site
Finland
- - Helsinki, Finland
    - Research Site
  - Jarvenpaa, Finland
    - Research Site
  - Salo, Finland
    - Research Site
  - Turku, Finland
    - Research Site
France
- - Angouleme, France
    - Research Site
  - Arcachon, France
    - Research Site
  - Caen, France
    - Research Site
  - Chateau Gontier, France
    - Research Site
  - Elancourt, France
    - Research Site
  - Le Pecq, France
    - Research Site
  - Nimes, France
    - Research Site
  - Paris, France
    - Research Site
  - Rennes, France
    - Research Site
  - Toulouse, France
    - Research Site
Germany
- - Augsburg, Germany
    - Research Site
  - Berlin, Germany
    - Research Site
  - Koln, Germany
    - Research Site
  - Munster, Germany
    - Research Site
Norway
- - Bergen, Norway
    - Research Site
  - Flekkefjord, Norway
    - Research Site
  - Fyllingsdalen, Norway
    - Research Site
  - Hamar, Norway
    - Research Site
  - Lysaker, Norway
    - Research Site
  - Oslo, Norway
    - Research Site
  - Skien, Norway
    - Research Site
Poland
- - Gdansk, Poland
    - Research Site
  - Lodz, Poland
    - Research Site
  - Nowy Targ, Poland
    - Research Site
  - Szczecin, Poland
    - Research Site
  - Torun, Poland
    - Research Site
  - Warszawa, Poland
    - Research Site
Romania
- - Bucharest, Romania
    - Research Site
  - Pitesti, Romania
    - Research Site
South Africa
- Gauteng
  - Pretoria, Gauteng, South Africa
    - Research Site
- Kwazulu-Natal
  - Durban, Kwazulu-Natal, South Africa
    - Research Site
- Western Cape
  - Cape Town, Western Cape, South Africa
    - Research Site
Sweden
- - Falkoping, Sweden
    - Research Site
  - Göteborg, Sweden
    - Research Site
  - Halmstad, Sweden
    - Research Site
  - Malmo, Sweden
    - Research Site
  - Stockholm, Sweden
    - Research Site
  - Sundsvall, Sweden
    - Research Site
  - Trollhattan, Sweden
    - Research Site
  - Uppsala, Sweden
    - 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female aged 18 to 65 years
A documented diagnosis of major depressive disorder

Exclusion Criteria:

Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

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: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the efficacy of quetiapine fumarate sustained release
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

Secondary Outcome Measures

Outcome Measure
If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

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, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D1448C00007
ONYX
EUDRACT No: 2005-0055053-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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.