Generalized Anxiety DisorderPhase 3SILVERNCT00322595
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
A Phase 3 study testing Quetiapine fumarate and Paroxetine in people with Generalized Anxiety Disorder, run by AstraZeneca at 86 sites in 15 countries.
Trial summary
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized 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
- Generalized Anxiety Disorder
- What is being tested?
- Quetiapine fumarate and Paroxetine
- How many people
- 800 participants
- Where
- 86 sitesin 15 countries
- Study dates
- May 2006to May 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
- Male or female aged 18 to 65 years;
- A diagnosis of generalized anxiety disorder;
- Absence of current episode of major depression.
Who cannot join
- The presence or history of schizophrenia and other psychotic disorders;
- Hypertension;
- A current diagnosis of cancer, unless in remission for at least 5 years
Trial locations and contacts
86 sites in 15 countries.
86 sites in 15 countries
Canada15 sites
Research Site
Brantford, Ontario
Research Site
Chatham, Ontario
Research Site
Corner Brook, Newfoundland and Labrador
Research Site
Gatineau, Quebec
Research Site
Kelowna, British Columbia
Research Site
Markham, Ontario
Research Site
Miramichi, New Brunswick
Research Site
Mississauga, Ontario
Research Site
Orléans, Ontario
Research Site
Ottawa, Ontario
Research Site
Saskatoon, Saskatchewan
Research Site
Sherbrooke, Quebec
Research Site
Sydney, Nova Scotia
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
France9 sites
Research Site
Angoulême
Research Site
Arcachon
Research Site
Cherbourg
Research Site
Élancourt
Research Site
La Valette-du-Var
Research Site
Le Pecq
Research Site
Nîmes
Research Site
Rennes
Research Site
Toulouse
Argentina7 sites
Research Site
Buenos Aires
Research Site
City Bell, Buenos Aires
Research Site
Córdoba
Research Site
Godoy Cruz, Mendoza Province
Research Site
La Plata
Research Site
Mendoza, Mendoza Province
Research Site
Rosario, Santa Fe Province
Czechia7 sites
Research Site
Brno
Research Site
Litoměřice
Research Site
Olomouc
Research Site
Pilsen
Research Site
Prague
Research Site
Prerova
Research Site
Prostojov
Germany7 sites
Research Site
Bad Saarow
Research Site
Berlin
Research Site
Bochum
Research Site
Göttingen
Research Site
Hamburg
Research Site
München
Research Site
Siegen
Bulgaria6 sites
Research Site
Kardzhali
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Research Site
Veliko Tarnovo
Research Site
Vratsa
Slovakia6 sites
Research Site
Bojnice
Research Site
Bratislava
Research Site
Brezno
Research Site
Košice
Research Site
Liptovský Mikuláš
Research Site
Zilina-Bytcica
Sweden5 sites
Research Site
Linköping
Research Site
Lund
Research Site
Malmö
Research Site
Sundsvall
Research Site
Uppsala
Finland4 sites
Research Site
Helsinki
Research Site
Jarvenpaa
Research Site
Salo
Research Site
Turku
South Africa4 sites
Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Durban
Research Site
Pretoria
Spain4 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Oviedo
Research Site
Salamanca
Denmark3 sites
Research Site
Aarhus
Research Site
Copenhagen
Research Site
Frederiksberg
Mexico3 sites
Research Site
Distrito Federal
Research Site
Guadalajara
Research Site
México
Romania3 sites
Research Site
Bucharest
Research Site
Piteşti
Research Site
Sibiu
About this study
Official title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized 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
- Generalized Anxiety Disorder
- Being tested
- Quetiapine fumarate, Paroxetine
- Keywords
- Anxiety, GAD
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
ParoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
Secondary outcomes (1)
To evaluate efficacy by evaluating response rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seroquel Medical Science Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322595
- Sponsor's protocol ID
- D1448C00011
- Other IDs
- 2005-005054-46, Silver, 2005
- Acronym
- SILVER
- Status last verified
- Dec 2007
- First submitted
- 5 May 2006
- Last updated
- 22 Dec 2008
- Results posted
- No
Publications
Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.
PubMed 24394383Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.
PubMed 22143997Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.
PubMed 19691907
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER)
- ClinicalTrials.gov ID
- NCT00322595
- Acronym / sponsor ID
- SILVER / D1448C00011
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Anxiety, GAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- May 2007 (actual)
- First posted
- 8 May 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 purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized 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 (3 listed)
- Male or female aged 18 to 65 years;
- A diagnosis of generalized anxiety disorder;
- Absence of current episode of major depression.
Key exclusion criteria (3 listed)
- The presence or history of schizophrenia and other psychotic disorders;
- Hypertension;
- A current diagnosis of cancer, unless in remission for at least 5 years
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 | Drug | – |
| Paroxetine | Drug | – |
Primary outcome
To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
1 secondary outcome
To evaluate efficacy by evaluating response rate.
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 22 Dec 2008.
- Derived from this study: PubMed 24394383Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.
- Derived from this study: PubMed 22143997Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.
- Derived from this study: PubMed 19691907Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010 Apr;13(3):305-20. doi: 10.1017/S1461145709990423. Epub 2009 Aug 20.
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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.
Seroquel Medical Science Director study director
AstraZeneca
86 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine fumarate and Paroxetine in people with Generalized Anxiety Disorder, run by AstraZeneca at 86 sites in 15 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 3 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 22 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in Canada, France, Argentina, Czechia, Germany and 10 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 compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).. 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 NCT00322595, which also lists 3 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 22 Dec 2008.