Generalized Anxiety Disorder Adjunct Study

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States

Intervention / Treatment
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* Drug: Placebo
* Drug: quetiapine fumarate XR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Adjunctive Placebo Seroquel XR to anxiety treatment | Drug: Placebo<br>* oral<br>|
| Experimental: 2<br>Adjunctive Seroquel XR to anxiety treatment | Drug: quetiapine fumarate XR<br>* oral<br>* Other names: Seroquel XR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized anxiety disorders, anxiety, adjunct treatment in anxiety, anxiety disorder, partial or non-responder in anxiety