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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389064
Recruitment Status : Completed
First Posted : October 18, 2006
Results First Posted : June 23, 2009
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: Quetiapine XR Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Quetapine XR
Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
 Drug: Quetiapine XR
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.
Placebo Comparator: Placebo
Matching placebo tablets orally administered once daily.
 Drug: Placebo
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: 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 :
  1. Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score [ Time Frame: 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


  2. Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: 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

  3. Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [ Time Frame: Randomization to Week 9 ]
    HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization

  4. Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [ Time Frame: Randomization to Week 9 ]
    HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization

  5. Hamilton Rating Scale for Anxiety (HAM-A) Response. [ Time Frame: Week 9 ]
    HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.

  6. Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission [ Time Frame: 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

  7. Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Randomization to week 9 ]
    MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization

  8. Change in the Visual Analogue Scale (VAS) Measuring Pain [ Time Frame: 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

  9. Safety and Well Tolerated as Measured in Adverse Event [ Time Frame: From the start of treatment to last dose plus 30 days ]
    Number of patients have at least one adverse event

  10. Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) [ Time Frame: From start of the study teatment to last dose plus 30 days ]
    Number of patients have adverse events associated with EPS


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389064


Locations
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United States, Florida
Research Site
Ft Myers, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Sarasota, Florida, United States
United States, Georgia
Research Site
Roswell, Georgia, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
Bronx, New York, United States
Research Site
Brooklyn, New York, United States
United States, Ohio
Research Site
Avon Lake, Ohio, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
United States, Pennsylvania
Research Site
Jenkintown, Pennsylvania, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
Research Site
Viljandi, Estonia
Poland
Research Site
Bialystok, Poland
Research Site
Gorlice, Poland
Research Site
Katowice, Poland
Research Site
Krakow, Poland
Research Site
Leszno, Poland
Research Site
Skorzewo, Poland
Research Site
Torun, Poland
Research Site
Wroclaw, Poland
Russian Federation
Research Site
Arkhangelsk, Russian Federation
Research Site
Izhevsk, Russian Federation
Research Site
Lipetsk, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Nizhny Novgorod, Russian Federation
Research Site
Perm, Russian Federation
Research Site
Saratov, Russian Federation
Research Site
St-petersburg, Russian Federation
Research Site
Stavropol, Russian Federation
Research Site
Voronezh, Russian Federation
Ukraine
Research Site
Glevakha, Kiev Region, Ukraine
Research Site
Dnepropetrovsk, Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Odessa, Ukraine
Research Site
Vinnitsa, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Ricardo Ruiz, MD AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00389064    
Other Study ID Numbers: D1448C00015
EUDRACT No: 2006-001195-21
First Posted: October 18, 2006    Key Record Dates
Results First Posted: June 23, 2009
Last Update Posted: April 4, 2012
Last Verified: March 2012
Keywords provided by AstraZeneca:
Generalised Anxiety Disorder
GAD
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
 Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs