Generalized Anxiety DisorderPhase 3TITANIUMNCT00329264
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder
A Phase 3 study testing Quetiapine fumarate in people with Generalized Anxiety Disorder, run by AstraZeneca at 58 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
- How many people
- 876 participants
- Where
- 58 sitesUnited States
- Study dates
- Apr 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
- 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
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Research Site
Allentown, Pennsylvania
Research Site
Atlanta, Georgia
Research Site
Austin, Texas
Research Site
Bellevue, Washington
Research Site
Brooklyn, New York
Research Site
Charleston, West Virginia
Research Site
Charlotte, North Carolina
Research Site
Cherry Hill, New Jersey
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Dallas, Texas
Research Site
Denver, Colorado
Research Site
Durham, North Carolina
Research Site
Eagle, Idaho
Research Site
Encino, California
Research SIte
Fall River, Massachusetts
Research Site
Farmington Hills, Michigan
Research Site
Fort Walton Beach, Florida
Research Site
Friendswood, Texas
Research Site
Gainsville, Florida
Research Site
Herndon, Virginia
Research Site
Hialeah, Florida
Research Site
Indianapolis, Indiana
Research Site
Jacksonville, Florida
Research Site
Las Vegas, Nevada
Research Site
Lincoln, Rhode Island
Research Site
Little Rock, Arkansas
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
Midlothian, Virginia
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Newport Beach, California
Research Site
Norristown, Pennsylvania
Research Site
Norwich, Connecticut
Research Site
Oak Brook, Illinois
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Portland, Oregon
Research Site
Redlands, California
Research Site
Ridgeland, Mississippi
Research Site
Rochester, New York
Research Site
San Antonio, Texas
Research Site
Santa Ana, California
Research Site
Seattle, Washington
Research Site
Smyrna, Georgia
Research Site
Springdale, Arizona
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
Tampa, Florida
Research Site
Toledo, Ohio
Research Site
Topeka, Kansas
Research Site
Tulsa, Oklahoma
Research Site
Washington D.C., District of Columbia
Research Site
Winter Park, Florida
Research Site
Woodstock, Vermont
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-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
- 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
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 completionAug 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
- 876 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Willie Earley, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329264
- Sponsor's protocol ID
- D1448C00009
- Other IDs
- Titanium
- Acronym
- TITANIUM
- 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 22143997Khan A, Joyce M, Atkinson S, Eggens I, Baldytcheva I, Eriksson H. A randomized, double-blind study of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder. J Clin Psychopharmacol. 2011 Aug;31(4):418-28. doi: 10.1097/JCP.0b013e318224864d.
PubMed 21694613
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 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
- NCT00329264
- Acronym / sponsor ID
- TITANIUM / D1448C00009
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD, anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Aug 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 | – |
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 21694613Khan A, Joyce M, Atkinson S, Eggens I, Baldytcheva I, Eriksson H. A randomized, double-blind study of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder. J Clin Psychopharmacol. 2011 Aug;31(4):418-28. doi: 10.1097/JCP.0b013e318224864d.
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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.
Willie Earley, MD study director
AstraZeneca
58 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 in people with Generalized Anxiety Disorder, run by AstraZeneca at 58 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 58 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 NCT00329264, 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.