Anxiety DisordersPhase 3PLATINUMNCT00314210
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
A Phase 3 study testing Quetiapine SR in people with Anxiety Disorders, run by AstraZeneca at 114 sites in 11 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Quetiapine SR
- How many people
- 575 participants
- Where
- 114 sitesin 11 countries
- Study dates
- Mar 2006to 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
- Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.
Who cannot join
- Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.
Trial locations and contacts
114 sites in 11 countries.
114 sites in 11 countries
United States56 sites
Research Site
Allentown, Pennsylvania
Research Site
Atlanta, Georgia
Research Site
Avon Lake, Ohio
Research Site
Beechwood, Ohio
Research Site
Boston, Massachusetts
Research Site
Cambridge, Massachusetts
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Cedarhurst, New York
Research Site
Cincinnati, Ohio
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Coeur d'Alene, Idaho
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Columbus, Georgia
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Coral Springs, Florida
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DeLand, Florida
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DeSoto, Texas
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Fort Myers, Florida
Research Site
Fresno, California
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Gainsville, Florida
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Glen Burnie, Maryland
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Havertown, Pennsylvania
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Hialeah, Florida
Research Site
Hoffman Estates, Illinois
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Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
La Mesa, California
Research Site
Lafayette, Indiana
Research Site
Libertyville, Illinois
Research Site
Marietta, Georgia
Research Site
Memphis, Tennessee
Research Site
Mesa, Arizona
Research SIte
Middleburg Heights, Ohio
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Midvale, Utah
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New York, New York
Research Site
North Charleston, South Carolina
Research Site
North Miami, Florida
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
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Owensboro, Kentucky
Research Site
Paducah, Kentucky
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Peoria, Arizona
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Phoenix, Arizona
Research Site
Piscataway, New Jersey
Research Site
Pittsburgh, Pennsylvania
Research Site
Pittsfield, Massachusetts
Research Site
Prairie Village, Kansas
Research Site
Redlands, California
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Richmond, Virginia
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Rochester, New York
Research Site
Roswell, Georgia
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Saint Charles, Missouri
Research Site
Saint Petersberg, Florida
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San Antonio, Texas
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Shreveport, Louisiana
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The Bronx, New York
Research Site
Toledo, Ohio
Research Site
Valparaiso, Indiana
Research Site
Wichita Falls, Texas
United Kingdom11 sites
Research Site
Blackpool
Research Site
Bolton
Research Site
Cardiff
Research Site
Chorley
Research Site
Coventry
Research Site
Crawley, West Sussex
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Glasgow
Research Site
Hamilton
Research Site
Liverpool
Research Site
Manchester
Research Site
Reading, Berkshire
Canada9 sites
Research Site
Bathurst, New Brunswick
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Edmonton, Alberta
Research Site
Gatineau, Quebec
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Hamilton, Ontario
Research Site
Kingston, Ontario
Research Site
Montreal, Quebec
Research Site
Orléans, Ontario
Research Site
Toronto, Ontario
Research Site
Waterloo, Ontario
Germany9 sites
Research Site
Berlin
Research Site
Göttingen
Research Site
Jena
Research Site
Leipzig
Research Site
München
Research Site
Naumburg
Research Site
Nuremberg
Research Site
Schwerin
Research Site
Siegen
Finland7 sites
Research Site
Helsinki
Research Site
Joensuu
Research Site
Kuopio
Research Site
Oulu
Research Site
Pori
Research Site
Seinäjoki
Research Site
Turku
Hungary6 sites
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Győr
Research Site
Gyula
Research Site
Kecskemét
Research Site
Nyíregyháza
Australia5 sites
Research Site
Brisbane, Queensland
Research Site
Everton Park, Queensland
Research Site
Malvern, Victoria
Research Site
Prahran, Victoria
Research Site
West Burleigh, Queensland
Philippines5 sites
Research Site
Cebu City
Research Site
Davao City
Research Site
Mandaluyong
Research Site
Manila
Research Site
Quezon City
Russia3 sites
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Saratov
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 SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Anxiety Disorders
- Being tested
- Quetiapine SR
- Keywords
- Generalised Anxiety Disorder
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomisation to occurrence of an anxiety event
Secondary outcomes (5)
Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startMar 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- 575 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Brecher, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314210
- Sponsor's protocol ID
- D1448C00012
- Other IDs
- EUDRACT Number: 2005-005055-18
- Acronym
- PLATINUM
- Status last verified
- Mar 2009
- First submitted
- 11 Apr 2006
- Last updated
- 25 Mar 2009
- Results posted
- No
Publications
Sheehan DV, Svedsater H, Locklear JC, Eriksson H. Effects of extended-release quetiapine fumarate on long-term functioning and sleep quality in patients with Generalized Anxiety Disorder (GAD): data from a randomized-withdrawal, placebo-controlled maintenance study. J Affect Disord. 2013 Dec;151(3):906-13. doi: 10.1016/j.jad.2013.07.037. Epub 2013 Aug 16.
PubMed 24135509
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 SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
- ClinicalTrials.gov ID
- NCT00314210
- Acronym / sponsor ID
- PLATINUM / D1448C00012
- Conditions
- Anxiety Disorders
- Keywords
- Generalised Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 13 Apr 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.
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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 (1 listed)
- Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.
Key exclusion criteria (1 listed)
- Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.
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 SR | Drug | – |
Primary outcome
Time from randomisation to occurrence of an anxiety event
5 secondary outcomes
Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
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 24135509Sheehan DV, Svedsater H, Locklear JC, Eriksson H. Effects of extended-release quetiapine fumarate on long-term functioning and sleep quality in patients with Generalized Anxiety Disorder (GAD): data from a randomized-withdrawal, placebo-controlled maintenance study. J Affect Disord. 2013 Dec;151(3):906-13. doi: 10.1016/j.jad.2013.07.037. Epub 2013 Aug 16.
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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.
Martin Brecher, MD study director
AstraZeneca
114 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine SR in people with Anxiety Disorders, run by AstraZeneca at 114 sites in 11 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 1 inclusion and 1 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 114 sites in United States, United Kingdom, Canada, Germany, Finland and 6 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?
Time from randomisation to occurrence of an anxiety event. 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 NCT00314210, which also lists 1 linked publication.
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.