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

Phase 3

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: Quetiapine XR; Drug: Placebo

• Registration Number: NCT00389064
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-18
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-15
• Results First Submitted QC: 2009-04-15
• Results First Posted: 2009-06-23
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetapine XR	Quetiapine XR	Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
Placebo	Placebo	Matching placebo tablets orally administered once daily.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score	Randomization to Week 9	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
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score	Randomization to Week 9	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
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score	Randomization to Week 9	HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score	Randomization to Week 9	HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Hamilton Rating Scale for Anxiety (HAM-A) Response.	Week 9	HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission	Week 9	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
Change in Montgomery-Asberg Depression Rating Scale (MADRS)	Randomization to week 9	MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Change in the Visual Analogue Scale (VAS) Measuring Pain	Randomization to week 9	Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Safety and Well Tolerated as Measured in Adverse Event	From the start of treatment to last dose plus 30 days	Number of patients have at least one adverse event
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)	From start of the study teatment to last dose plus 30 days	Number of patients have adverse events associated with EPS

Trial Locations

Locations (1)

Research Site; 🇺🇦 Vinnitsa, Ukraine