Clinical trial NCT00534599: Generalized Anxiety Disorder Adjunct 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Baseline (randomization) and then 8 weeks
Secondary outcomes:
measure: Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
timeFrame: Baseline (randomization) and then 8 weeks
measure: Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Least Square Mean Change From Randomization to Week 1 in CGI-S Score
timeFrame: Baseline (randomization) and then 8 weeks
measure: Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
timeFrame: Baseline (randomization) and then 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Encino
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Dayton
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Lafayette
country: United States
facility: Research Site
state: Indiana
city: Merrillville
country: United States
facility: Research Site
state: Indiana
city: Terre Haute
country: United States
facility: Research Site
state: Indiana
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Owenboro
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Cedarhurst
country: United States
facility: Research Site
state: New York
city: Fresh Meadows
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Witchita Falls
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Martin Brecher, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. 2013 Nov;25(4):E7-22.