AnxietyPhase 3NCT00534599
Generalized Anxiety Disorder Adjunct Study
A Phase 3 study testing quetiapine fumarate XR in people with Anxiety and Anxiety Disorders, run by AstraZeneca at 53 sites in United States.
Trial summary
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Anxiety Disorders, Anxiety Neuroses
- What is being tested?
- quetiapine fumarate XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 53 sitesUnited States
- Study dates
- Aug 2007to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provision of Informed Consent
- Documented diagnosis of Generalized Anxiety Disorder
- Female patients must not be pregnant and be willing to use a reliable method of birth control
- Be able to understand and comply with study requirements
Who cannot join
- Other psychiatric disorders that could confound the study results, as judged by the study doctor
- Moderate to severe depression
- Other clinically relevant diseases, as judged by the study doctor
- Medication that you are taking, as judged by the study doctor
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Research Site
Atlanta, Georgia
Research Site
Bellevue, Washington
Research Site
Beverly Hills, California
Research Site
Birmingham, Alabama
Research Site
Boston, Massachusetts
Research Site
Bradenton, Florida
Research Site
Brooklyn, New York
Research Site
Cedarhurst, New York
Research Site
Cherry Hill, New Jersey
Research Site
Chicago, Illinois
Research Site
Clementon, New Jersey
Research Site
Columbus, Georgia
Research Site
Dayton, Florida
Research Site
Encino, California
Research Site
Fresh Meadows, New York
Research Site
Fresno, California
Research Site
Hialeah, Florida
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
La Mesa, California
Research Site
Lafayette, Indiana
Research Site
Little Rock, Arkansas
Research Site
Maitland, Florida
Research Site
Memphis, Tennessee
Research Site
Merrillville, Indiana
Research Site
Miami, Florida
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
North Miami, Florida
Research Site
Oceanside, California
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Owenboro, Kentucky
Research Site
Philadelphia, Pennsylvania
Research Site
Portland, Oregon
Research Site
Prairie Village, Kansas
Research Site
Redlands, California
Research Site
Richmond, Virginia
Research Site
Rochester, New York
Research Site
Rockville, Maryland
Research Site
Salem, Oregon
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
San Francisco, California
Research Site
Seattle, Washington
Research Site
Sherman Oaks, California
Research Site
Spokane, Washington
Research Site
Staten Island, New York
Research Site
Tampa, Florida
Research Site
Terre Haute, Indiana
Research Site
Toledo, Ohio
Research Site
West Palm Beach, Florida
Research Site
Witchita Falls, Texas
About this study
Official title: A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States
- Being tested
- Placebo, quetiapine fumarate XR
- Keywords
- Generalized anxiety disorders, anxiety, adjunct treatment in anxiety, anxiety disorder, partial or non-responder in anxiety
- 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.
PlaceboDrug
oral
quetiapine fumarate XRDrug
Also called Seroquel XR
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Adjunctive Placebo Seroquel XR to anxiety treatment Receives: Drug: Placebo |
| 2 | Experimental | Adjunctive Seroquel XR to anxiety treatment Receives: Drug: quetiapine fumarate XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
Measured: Baseline (randomization) and then 8 weeks
Secondary outcomes (14)
Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8
This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in CGI-S Score
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).
Results based on MITT population with available data for this outcome measure.
Measured: Baseline (randomization) and then 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
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
- NCT00534599
- Sponsor's protocol ID
- D1441L00016
- Status last verified
- Apr 2011
- First submitted
- 24 Sep 2007
- Last updated
- 14 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2014 Feb;26(1):3-18.
PubMed 24660224Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2013 Nov;25(4):E7-22.
PubMed 24199224
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo
- ClinicalTrials.gov ID
- NCT00534599
- Acronym / sponsor ID
- D1441L00016
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States
- Keywords
- Generalized anxiety disorders, anxiety, adjunct treatment in anxiety, anxiety disorder, partial or non-responder in anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 5 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: PlaceboAdjunctive Placebo Seroquel XR to anxiety treatment |
| 2 | Experimental | Drug: quetiapine fumarate XRAdjunctive Seroquel XR to anxiety treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of Informed Consent
- Documented diagnosis of Generalized Anxiety Disorder
- Female patients must not be pregnant and be willing to use a reliable method of birth control
- Be able to understand and comply with study requirements
Key exclusion criteria (4 listed)
- Other psychiatric disorders that could confound the study results, as judged by the study doctor
- Moderate to severe depression
- Other clinically relevant diseases, as judged by the study doctor
- Medication that you are taking, as judged by the study doctor
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 |
|---|---|---|
| Placebooral | Drug | 1 |
| quetiapine fumarate XRAlso: Seroquel XRoral | Drug | 2 |
Primary outcome
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: Baseline (randomization) and then 8 weeks
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
14 secondary outcomes
Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
Time frame: Baseline (randomization) and then 8 weeks
Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
Time frame: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
Time frame: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
Time frame: Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
Time frame: Baseline (randomization) and then 8 weeks
Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
Time frame: Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 1 in CGI-S Score
Time frame: Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
Time frame: Baseline (randomization) and then 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24660224Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2014 Feb;26(1):3-18.
- Derived from this study: PubMed 24199224Khan A, Atkinson S, Mezhebovsky I, She F, Leathers T, Pathak S. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with generalized anxiety disorder and a history of inadequate treatment response: a randomized, double-blind study. Ann Clin Psychiatry. 2013 Nov;25(4):E7-22.
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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
53 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 XR in people with Anxiety and Anxiety Disorders, run by AstraZeneca at 53 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 4 inclusion and 4 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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 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?
Yes. Results are posted in the registry (first posted 5 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score (time frame: Baseline (randomization) and then 8 weeks). 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 NCT00534599, 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 14 Apr 2011.