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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326144
First Posted: May 16, 2006
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
May 15, 2006
May 16, 2006
March 25, 2009
April 2006
Not Provided
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
Same as current
Complete list of historical versions of study NCT00326144 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Quetiapine fumarate
Other Name: Seroquel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
May 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00326144
D1448C00003
OPAL
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

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