Generalized Anxiety Disorder Adjunct Study

Phase 3

Completed

• Conditions: Anxiety Neuroses; Anxiety States; Anxiety; Anxiety Disorders
• Interventions: Drug: Placebo; Drug: quetiapine fumarate XR

• Registration Number: NCT00534599
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-08-13
• Results First Submitted QC: 2011-03-06
• Status Verified: 2011-04
• Results First Posted: 2011-04-05
• Last Update Submitted: 2011-04-12
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 409

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Adjunctive Placebo Seroquel XR to anxiety treatment
2	quetiapine fumarate XR	Adjunctive Seroquel XR to anxiety treatment

Primary Outcome Measures

Name	Time	Method
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score	Baseline (randomization) and then 8 weeks	Results based on MITT population with available data for this outcome measure.
Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score	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 Change From Randomization to Week 1 in CGI-S Score	Baseline (randomization) and then 8 weeks	Results based on MITT population with available data for this outcome measure.
Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score	Baseline (randomization) and then 8 weeks	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.
Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score	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.
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	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.
Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score	Baseline (randomization) and then 8 weeks	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.
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8	Baseline (randomization) and then 8 weeks	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.
Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8	Baseline (randomization) and then 8 weeks	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.
Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score	Baseline (randomization) and then 8 weeks	Results based on MITT population with available data for this outcome measure.
Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1	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 Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score	Baseline (randomization) and then 8 weeks	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.
Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Spokane, Washington, United States