Generalized Anxiety Disorder Adjunct Study

AstraZeneca409 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

409

Conditions

Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States

Interventions

PlaceboDRUG

oral

quetiapine fumarate XRDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (53)

Outcomes

Primary Outcomes

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.

Time frame: Baseline (randomization) and then 8 weeks

Secondary Outcomes

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.

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

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.

Time frame: 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.

Time frame: Baseline (randomization) and then 8 weeks

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Beverly Hills, California, United States

Research Site

Encino, California, United States

Research Site

Fresno, California, United States

Research Site

La Mesa, California, United States

Research Site

Oceanside, California, United States

Research Site

Redlands, California, United States

Research Site

San Diego, California, United States

Research Site

San Francisco, California, United States

...and 43 more locations

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.

Time frame: 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.

Time frame: 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.

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

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.

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

Results based on MITT population with available data for this outcome measure.

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

Results based on MITT population with available data for this outcome measure.

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

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.

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

Results based on MITT population with available data for this outcome measure.

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