Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

July 12, 2006

Last Updated Date

December 18, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00351910 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: Quetiapine
Drug: Amitriptyline
Drug: Bupropion
Drug: Citalopram
Drug: Duloxetine
Drug: Escitalopram
Drug: Fluoxetine
Drug: Paroxetine
Drug: Sertraline
Drug: Venlafaxine

Study Arms / Comparison Groups

Publications *

Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. Epub 2009 Apr 7.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

494

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Norway, Poland, Romania, South Africa, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00351910

Responsible Party

Study ID Numbers ^ICMJE

D1448C00007, ONYX, EUDRACT No: 2005-0055053-22

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP