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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00389064
First received: October 17, 2006
Last updated: March 30, 2012
Last verified: March 2012

October 17, 2006
March 30, 2012
September 2006
April 2008   (final data collection date for primary outcome measure)
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
The primary objective of this study is to evaluate the change in the Hamilton Rating Scale for Anxiety (HAM-A) total score, from randomisation to the end of the treatment (Day 64).
Complete list of historical versions of study NCT00389064 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Randomization to week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the start of treatment to last dose plus 30 days ] [ Designated as safety issue: Yes ]
    Number of patients have at least one adverse event
  • 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 ] [ Designated as safety issue: Yes ]
    Number of patients have adverse events associated with EPS
The secondary objectives are to evaluate the changes (e.g. in anxiety symptoms, health-related quality of life and remission rate) by questionnaires, from randomisation to the end of the treatment (Day 64).
Not Provided
Not Provided
 
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorders
  • 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.
  • 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.
  • Experimental: Quetapine XR
    Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
    Intervention: Drug: Quetiapine XR
  • Placebo Comparator: Placebo
    Matching placebo tablets orally administered once daily.
    Intervention: Drug: Placebo
Mezhebovsky I, Mägi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
66 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Estonia,   Poland,   Russian Federation,   Ukraine
 
NCT00389064
D1448C00015, EUDRACT No: 2006-001195-21
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Ricardo Ruiz, MD AstraZeneca
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP