Generalized Anxiety Disorder Adjunct Study
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
1 other identifier
interventional
409
1 country
53
Brief 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 or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 anxiety
Started Aug 2007
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 24, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
April 5, 2011
CompletedApril 14, 2011
April 1, 2011
1.1 years
September 24, 2007
August 13, 2009
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
Baseline (randomization) and then 8 weeks
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
Baseline (randomization) and then 8 weeks
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
Baseline (randomization) and then 8 weeks
- +9 more secondary outcomes
Study Arms (2)
1
OTHERAdjunctive Placebo Seroquel XR to anxiety treatment
2
EXPERIMENTALAdjunctive Seroquel XR to anxiety treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (53)
Research Site
Birmingham, Alabama, United States
Research Site
Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Encino, California, United States
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Fresno, California, United States
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La Mesa, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Sherman Oaks, California, United States
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Bradenton, Florida, United States
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Dayton, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Chicago, Illinois, United States
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Lafayette, Indiana, United States
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Merrillville, Indiana, United States
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Terre Haute, Indiana, United States
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Prairie Village, Kansas, United States
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Owenboro, Kentucky, United States
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New Orleans, Louisiana, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
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Brooklyn, New York, United States
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Cedarhurst, New York, United States
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Fresh Meadows, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Witchita Falls, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
Related Publications (2)
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.
PMID: 24660224DERIVEDKhan 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.
PMID: 24199224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Martin Brecher, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 24, 2007
First Posted
September 26, 2007
Study Start
August 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
April 14, 2011
Results First Posted
April 5, 2011
Record last verified: 2011-04