Major Depressive DisorderPhase 3AMETHYSTNCT00278941

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

A Phase 3 study testing Quetiapine Fumarate Sustained Release in people with Major Depressive Disorder, run by AstraZeneca at 168 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Quetiapine Fumarate Sustained Release
How many people: 3,000 participants
Where: 168 sitesin 8 countries
Study dates: Dec 2005to Aug 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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,

Who cannot join

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

Trial locations and contacts

168 sites in 8 countries.

Country

City, postcode or hospital

168 sites in 8 countries

United States144 sites

Research Site
Allentown, Pennsylvania
Research Site
Altamonte Springs, Florida
Research Site
Anaheim, California
Research Site
Atlanta, Georgia
Research Site
Augusta, Georgia
Research Site
Avon Lake, Ohio
Research Site
Bala-Cynwyd, Pennsylvania
Research Site
Baltimore, Maryland
Research Site
Birmingham, Alabama
Research Site
Bloomfield Hills, Michigan
Research Site
Boston, Massachusetts
Research Site
Brooklyn, New York
Research Site
Cambridge, Massachusetts
Research Site
Canton, Ohio
Research Site
Cedarhurst, New York
Research Site
Cerritos, California
Research Site
Chagrin Falls, Ohio
Research Site
Charleston, South Carolina
Research Site
Charlotte, North Carolina
Research Site
Charlottesville, Virginia
Research Site
Cherry Hill, New Jersey
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
City of Saint Peters, Missouri
Research Site
Clearwater, Florida
Research Site
Cleveland, Ohio
Research Site
Clinton Twp, Michigan
Research Site
Coatesville, Pennsylvania
Research Site
Coeur d'Alene, Idaho
Research Site
Colorado Springs, Colorado
Research Site
Columbus, Georgia
Research Site
Coral Springs, Florida
Research Site
Costa Mesa, California
Research Site
Cromwell, Connecticut
Research Site
Decatur, Georgia
Research Site
DeLand, Florida
Research Site
DeSoto, Texas
Research Site
El Centro, California
Research Site
Eugene, Oregon
Research Site
Fall River, Massachusetts
Research Site
Farmington, Connecticut
Research Site
Farmington Hills, Michigan
Research Site
Flowood, Mississippi
Research Site
Fort Myers, Florida
Research Site
Fresno, California
Research Site
Friendswood, Texas
Research Site
Gainsville, Florida
Research Site
Glen Burnie, Maryland
Research Site
Granite City, Illinois
Research Site
Greensboro, North Carolina
Research Site
Greer, South Carolina
Research Site
Havertown, Pennsylvania
Research Site
Hialeah, Florida
Research Site
Hoffman Estates, Illinois
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Jenkintown, Pennsylvania
Research Site
Kenilworth, New Jersey
Research Site
La Mesa, California
Research Site
Lafayette, Indiana
Research Site
Lake Jackson, Texas
Research Site
Las Vegas, Nevada
Research Site
Libertyville, Illinois
Research Site
Lincoln, Rhode Island
Research Site
Little Rock, Arkansas
Research Site
Los Angeles, California
Research Site
Media, Pennsylvania
Research Site
Memphis, Tennessee
Research Site
Mesa, Arizona
Research Site
Miami, Florida
Research Site
Middleburg Heights, Ohio
Research Site
Middletown, Connecticut
Research Site
Midlothian, Virginia
Research Site
Midvale, Utah
Research Site
Milwaukee, Wisconsin
Research Site
Minneapolis, Minnesota
Research Site
Moon Township, Pennsylvania
Research Site
Mount Kisco, New York
Research Site
Nashville, Tennessee
Research Site
New Port Richey, Florida
Research Site
New York, New York
Research Site
North Miami, Florida
Research Site
Northfield, Illinois
Research Site
Ocala, Florida
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Olean, New York
Research Site
Orlando, Florida
Research Site
Owensboro, Kentucky
Research Site
Palm Beach Gardens, Florida
Research Site
Pasadena, California
Research Site
Peoria, Arizona
Research Site
Pico Rivera, California
Research Site
Pittsburgh, Pennsylvania
Research Site
Pittsfield, Massachusetts
Research Site
Portage, Michigan
Research Site
Prairie Village, Kansas
Research Site
Princeton, New Jersey
Research Site
Providence, Rhode Island
Research Site
Pueblo, Colorado
Research Site
Reading, Pennsylvania
Research Site
Redlands, California
Research Site
Richmond, Virginia
Research Site
Ridgeland, Mississippi
Research Site
Riverside, California
Research Site
Rochester, New York
Research Site
Rochester Hills, Michigan
Research Site
Rockville, Maryland
Research Site
Roswell, Georgia
Research Site
Saint Charles, Missouri
Research Site
Saint Petersberg, Florida
Research Site
Salem, Oregon
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Sandy Springs, Georgia
Research Site
Santa Ana, California
Research Site
Sarasota, Florida
Research Site
Shreveport, Louisiana
Research Site
Sioux Falls, South Dakota
Research Site
Skokie, Illinois
Research Site
Spokane, Washington
Research Site
Springfield, Massachusetts
Research Site
St Louis, Missouri
Research Site
Stanford, California
Research Site
Stuart, Florida
Research Site
Terre Haute, Indiana
Research Site
Toledo, Ohio
Research Site
Toms River, New Jersey
Research Site
Topeka, Kansas
Research Site
Torrance, California
Research Site
Tulsa, Oklahoma
Research Site
Tuscaloosa, Alabama
Research Site
Upland, California
Research Site
Valparaiso, Indiana
Research Site
Virginia Beach, Virginia
Research Site
Vista, California
Research Site
Walnut Creek, California
Research Site
Washington D.C., District of Columbia
Research Site
West Palm Beach, Florida
Research Site
Wichita Falls, Texas
Research Site
Wilmington, Delaware
Research Site
Winston-Salem, North Carolina
Research Site
Woodstock, Vermont
Research Site
Worcester, Massachusetts

Other trials in United States

Canada10 sites

Research Site
Burlington, Ontario
Research Site
Gatineau, Quebec
Research Site
Miramichi, New Brunswick
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
Ottawa, Ontario
Research Site
Québec, Quebec
Research Site
Sherbrooke, Quebec
Research Site
Vancouver, British Columbia
Research Site
Victoria, British Columbia

Other trials in Canada

Slovakia4 sites

Research Site
Piešťany
Research Site
Prešov
Research Site
Sereď
Research Site
Trenčín

Other trials in Slovakia

Romania3 sites

Research Site
Bucharest
Research Site
Iași
Research Site
Piteşti

Other trials in Romania

United Kingdom3 sites

Research Site
Ayrshire
Research Site
Glasgow
Research Site
Reading

Other trials in United Kingdom

Russia2 sites

Research Site
Moscow
Research Site
Saint Petersburg

Other trials in Russia

Bulgaria1 site

Research Site
Vratsa

Other trials in Bulgaria

Puerto Rico1 site

Research Site
Rio Predia

Other trials in Puerto Rico

About this study

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

Conditions: Major Depressive Disorder
Being tested: Quetiapine Fumarate Sustained Release
Keywords: Seroquel SR™, Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quetiapine Fumarate Sustained ReleaseDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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 outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Aug 2007

First posted19 Jan 2006 (estimated)
Study startDec 2005
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 3,000 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00278941
Sponsor's protocol ID: D1448C00005
Other IDs: Amethyst
Acronym: AMETHYST
Status last verified: Mar 2009
First submitted: 17 Jan 2006
Last updated: 25 Mar 2009
Results posted: No

Publications

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.
PubMed 24816198
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.
PubMed 24175720

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00278941
Acronym / sponsor ID: AMETHYST / D1448C00005
Conditions: Major Depressive Disorder
Keywords: Seroquel SR™, Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,000 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2005
Study completion: Aug 2007 (actual)
First posted: 19 Jan 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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,

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quetiapine Fumarate Sustained Release	Drug	–

Primary outcome

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)

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
Derived from this study: PubMed 24816198Weisler 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.
Derived from this study: PubMed 24175720Weisler 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.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Seroquel Medical Science Director, MD study director

AstraZeneca

168 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine Fumarate Sustained Release in people with Major Depressive Disorder, run by AstraZeneca at 168 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, Canada, Slovakia, Romania, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00278941, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.