Generalized Anxiety DisorderPhase 3GOLDNCT00329446
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
A Phase 3 study testing Quetiapine Fumarate and Escitalopram oxylate in people with Generalized Anxiety Disorder, run by AstraZeneca at 63 sites in United States.
Trial summary
The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA. 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 Escitalopram oxylate
- How many people
- 800 participants
- Where
- 63 sitesUnited States
- Study dates
- Apr 2006to Sep 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
- Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
Who cannot join
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Research Site
Albuquerque, New Mexico
Research Site
Allentown, Pennsylvania
Research Site
Baltimore, Maryland
Research Site
Beverly Hills, California
Research Site
Birmingham, Alabama
Research Site
Boca Raton, Florida
Research Site
Boston, Massachusetts
Research Site
Bradenton, Florida
Research Site
Burbank, California
Research Site
Chapel Hill, North Carolina
Research Site
Cleveland, Ohio
Research Site
Columbia, South Carolina
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
DeLand, Florida
Research Site
Edwardsville, Illinois
Research Site
Eugene, Oregon
Research Site
Fort Lauderdale, Florida
Research Site
Fort Myers, Florida
Research Site
Haverhill, Massachusetts
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Kenilworth, New Jersey
Research Site
Kirkland, Washington
Research Site
La Mesa, California
Research Site
Lake Charles, Louisiana
Research Site
Little Rock, Arkansas
Research Site
Maitland, Florida
Research Site
Memphis, Tennessee
Research Site
Merrillville, Indiana
Research Site
Miami, Florida
Research Site
Morgantown, West Virginia
Research Site
Nashville, Tennessee
Research Site
New Britain, Connecticut
Research Site
New York, New York
Research Site
Newton, Kansas
Research Site
Okemos, Michigan
Research Site
Oklahoma City, Oklahoma
Research Site
Orange, California
Research Site
Orlando, Florida
Research Site
Owensboro, Kentucky
Research Site
Pasadena, California
Research Site
Philadelphia, Pennsylvania
Research Site
Prairie Village, Kansas
Research Site
Princeton, New Jersey
Research Site
Richmond, Virginia
Research Site
Saint Paul, Minnesota
Research Site
Salem, Oregon
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Scottsdale, Arizona
Research Site
Sherman Oaks, California
Research Site
Spokane, Washington
Research Site
St Louis, Missouri
Research Site
Tampa, Florida
Research Site
Terre Haute, Indiana
Research Site
Toledo, Ohio
Research Site
Toms River, New Jersey
Research Site
Upland, California
Research Site
Washington D.C., District of Columbia
Research Site
West Palm Beach, Florida
Research Site
Wildomar, California
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder
The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder.
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, Escitalopram oxylate
- Keywords
- GAD, anxiety
- 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
Escitalopram oxylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from randomization in the HAM-A total score at Day 57
Secondary outcomes (1)
Change from randomization in CGI-S score at Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startApr 2006
- Study completionSep 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
- Anders Neijber, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329446
- Sponsor's protocol ID
- D1448C00010
- Other IDs
- GOLD
- Acronym
- GOLD
- Status last verified
- Mar 2009
- First submitted
- 22 May 2006
- Last updated
- 25 Mar 2009
- 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 22143997Merideth C, Cutler AJ, She F, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study. Int Clin Psychopharmacol. 2012 Jan;27(1):40-54. doi: 10.1097/YIC.0b013e32834d9f49.
PubMed 22045039
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 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00329446
- Acronym / sponsor ID
- GOLD / D1448C00010
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD, anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 24 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 purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder.
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)
- Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
Key exclusion criteria (2 listed)
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
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 | – |
| Escitalopram oxylate | Drug | – |
Primary outcome
Change from randomization in the HAM-A total score at Day 57
1 secondary outcome
Change from randomization in CGI-S score at Day 57
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 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 22045039Merideth C, Cutler AJ, She F, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study. Int Clin Psychopharmacol. 2012 Jan;27(1):40-54. doi: 10.1097/YIC.0b013e32834d9f49.
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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.
Anders Neijber, MD study director
AstraZeneca
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine Fumarate and Escitalopram oxylate in people with Generalized Anxiety Disorder, run by AstraZeneca at 63 sites in United States.
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 2 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 63 sites in United States. 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?
Change from randomization in the HAM-A total score at Day 57. 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 NCT00329446, 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 25 Mar 2009.