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Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder (AMETHYST)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine Fumarate Sustained Release
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 Seroquel SR™, Major Depressive Disorder

Eligibility Criteria

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

Inclusion Criteria: Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Exclusion Criteria: Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment, Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status. Patients whose current episode of depression>12 months or <4 weeks from enrollment

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Outcomes

Primary Outcome Measures

To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)

Secondary Outcome Measures

Evaluate quetiapine SR compared to placebo on health related quality of life.

Full Information

First Posted
January 17, 2006
Last Updated
March 24, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00278941
Brief Title
Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Acronym
AMETHYST
Official Title
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction 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
Seroquel SR™, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate Sustained Release
Primary Outcome Measure Information:
Title
To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
Secondary Outcome Measure Information:
Title
Evaluate quetiapine SR compared to placebo on health related quality of life.

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: Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Exclusion Criteria: Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment, Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status. Patients whose current episode of depression>12 months or <4 weeks from enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
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Birmingham
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Tuscaloosa
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Lincoln
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Providence
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Charleston
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Greer
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Memphis
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Friendswood
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Houston
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Lake Jackson
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San Antonio
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Midvale
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Woodstock
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Vermont
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Charlottesville
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Midlothian
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Richmond
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Virginia Beach
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United States
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Spokane
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United States
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Milwaukee
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Wisconsin
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United States
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Vratza
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Bulgaria
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Vancouver
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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Miramichi
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New Brunswick
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Canada
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Burlington
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Ontario
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Canada
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Mississauga
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Ontario
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Canada
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Ottawa
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Ontario
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Canada
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Gatineau
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Quebec
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Canada
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Montreal
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Quebec
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Canada
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Sherbrooke
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Quebec
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Canada
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Quebec
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Canada
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Rio Predia
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Puerto Rico
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Bucharest
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Romania
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Iasi
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Romania
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Pitesti
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Romania
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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Piestany
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Slovakia
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Presov
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Slovakia
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Sered
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Slovakia
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Trencin
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Slovakia
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Ayrshire
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United Kingdom
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Glasgow
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United Kingdom
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Reading
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United Kingdom

12. IPD Sharing Statement

Citations:
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

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Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

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