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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine fumarate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
May 15, 2006
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00326144
Brief Title
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
Acronym
OPAL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Other Intervention Name(s)
Seroquel
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo
Title
To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
El Centro
State/Province
California
Country
United States
Facility Name
Research Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Research Site
City
National City
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
Research Site
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Naperville
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Braintree
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Cambridge
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Pittsfield
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research SIte
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Research Site
City
Avon Lake
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
DeSoto
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26474010
Citation
McIntyre RS, Gorwood P, Thase ME, Liss C, Desai D, Chen J, Bauer M. Early Symptom Improvement as a Predictor of Response to Extended Release Quetiapine in Major Depressive Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):706-10. doi: 10.1097/JCP.0000000000000416.
Results Reference
derived
PubMed Identifier
24816198
Citation
Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.
Results Reference
derived
PubMed Identifier
24175720
Citation
Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.
Results Reference
derived
PubMed Identifier
24067192
Citation
Clayton AH, Locklear JC, Svedsater H, McIntyre RS. Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate. CNS Spectr. 2014 Apr;19(2):182-96. doi: 10.1017/S1092852913000631. Epub 2013 Sep 25.
Results Reference
derived
PubMed Identifier
23485955
Citation
Thase ME, Montgomery S, Papakostas GI, Bauer M, Trivedi MH, Svedsater H, Locklear JC, Gustafsson U, Datto C, Eriksson H. Quetiapine XR monotherapy in major depressive disorder: a pooled analysis to assess the influence of baseline severity on efficacy. Int Clin Psychopharmacol. 2013 May;28(3):113-20. doi: 10.1097/YIC.0b013e32835fb971.
Results Reference
derived
PubMed Identifier
20691481
Citation
Bortnick B, El-Khalili N, Banov M, Adson D, Datto C, Raines S, Earley W, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in major depressive disorder: a placebo-controlled, randomized study. J Affect Disord. 2011 Jan;128(1-2):83-94. doi: 10.1016/j.jad.2010.06.031. Epub 2010 Aug 6.
Results Reference
derived

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

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