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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine XR
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Generalised Anxiety Disorder, GAD

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quetapine XR

Placebo

Arm Description

Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.

Matching placebo tablets orally administered once daily.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
Hamilton Rating Scale for Anxiety (HAM-A) Response.
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
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)
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
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
Number of patients have at least one adverse event
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Number of patients have adverse events associated with EPS

Full Information

First Posted
October 17, 2006
Last Updated
March 30, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00389064
Brief Title
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Generalised Anxiety Disorder, GAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetapine XR
Arm Type
Experimental
Arm Description
Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets orally administered once daily.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
Primary Outcome Measure Information:
Title
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
Time Frame
Randomization to Week 9
Secondary Outcome Measure Information:
Title
Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
Description
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
Time Frame
Randomization to Week 9
Title
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Description
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
Time Frame
Randomization to Week 9
Title
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
Description
HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Time Frame
Randomization to Week 9
Title
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
Description
HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Time Frame
Randomization to Week 9
Title
Hamilton Rating Scale for Anxiety (HAM-A) Response.
Description
HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Time Frame
Week 9
Title
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
Description
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
Time Frame
Week 9
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Time Frame
Randomization to week 9
Title
Change in the Visual Analogue Scale (VAS) Measuring Pain
Description
Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Time Frame
Randomization to week 9
Title
Safety and Well Tolerated as Measured in Adverse Event
Description
Number of patients have at least one adverse event
Time Frame
From the start of treatment to last dose plus 30 days
Title
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Description
Number of patients have adverse events associated with EPS
Time Frame
From start of the study teatment to last dose plus 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Ruiz, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ft Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Gainsville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Roswell
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
Avon Lake
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Viljandi
Country
Estonia
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Gorlice
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Leszno
Country
Poland
Facility Name
Research Site
City
Skorzewo
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
Country
Russian Federation
Facility Name
Research Site
City
Lipetsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Perm
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
St-petersburg
Country
Russian Federation
Facility Name
Research Site
City
Stavropol
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
Country
Russian Federation
Facility Name
Research Site
City
Glevakha
State/Province
Kiev Region
Country
Ukraine
Facility Name
Research Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
23070803
Citation
Mezhebovsky I, Magi K, She F, Datto C, Eriksson H. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013 Jun;28(6):615-25. doi: 10.1002/gps.3867. Epub 2012 Oct 16.
Results Reference
derived

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

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