Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
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A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: Quetiapine XR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, 66 years or older, with a documented clinical diagnosis of Generalised Anxiety Disorder (GAD). Absence of current episode of major depression. Exclusion Criteria: The presence of dementia or other mental disorder than GAD. Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse. A current diagnosis of cancer or current or past diagnosis of stroke.

Ages Eligible for Study
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Minimum Age: 66 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 |
| --- | --- |
| Experimental: Quetapine XR<br>Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. | Drug: Quetiapine XR<br>* Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets orally administered once daily. | Drug: Placebo<br>* Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization | Randomization to Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score | Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 9 minus percentage at randomization | Randomization to Week 9 | 
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization | Randomization to Week 9 | 
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization | Randomization to Week 9 | 
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization | Randomization to Week 9 | 
| Hamilton Rating Scale for Anxiety (HAM-A) Response. | HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score. | Week 9 | 
| Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission | HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as: If HAM-A total score≤7, THEN indicator=1 If HAM-A total score >7, THEN indicator=0 | Week 9 | 
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization | Randomization to week 9 | 
| Change in the Visual Analogue Scale (VAS) Measuring Pain | Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization | Randomization to week 9 | 
| Safety and Well Tolerated as Measured in Adverse Event | Number of patients have at least one adverse event | From the start of treatment to last dose plus 30 days | 
| Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) | Number of patients have adverse events associated with EPS | From start of the study teatment to last dose plus 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalised Anxiety Disorder, GAD