Generalized Anxiety Disorder Adjunct Study

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534599
• Other study ID #: D1441L00016
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2007
• Last updated: April 12, 2011
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Anxiety Neuroses
• Anxiety States
• Disease

Intervention

Drug:
• Placebo
oral
• quetiapine fumarate XR
oral

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bellevue	Washington
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bradenton	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Cedarhurst	New York
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Chicago	Illinois
United States	Research Site	Clementon	New Jersey
United States	Research Site	Columbus	Georgia
United States	Research Site	Dayton	Florida
United States	Research Site	Encino	California
United States	Research Site	Fresh Meadows	New York
United States	Research Site	Fresno	California
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	La Mesa	California
United States	Research Site	Lafayette	Indiana
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Merrillville	Indiana
United States	Research Site	Miami	Florida
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	North Miami	Florida
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Owenboro	Kentucky
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Redlands	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rockville	Maryland
United States	Research Site	Salem	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	Seattle	Washington
United States	Research Site	Sherman Oaks	California
United States	Research Site	Spokane	Washington
United States	Research Site	Staten Island	New York
United States	Research Site	Tampa	Florida
United States	Research Site	Terre Haute	Indiana
United States	Research Site	Toledo	Ohio
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Witchita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No
Secondary	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.	Baseline (randomization) and then 8 weeks	No