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Completed

NCT Number: NCT00389064

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

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.

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Key information

Conditions

Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Tartu, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine XR

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2006
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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