Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Anxiety Disorders
Drug: Quetiapine XR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


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 [ 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


Enrollment: 450
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389064

  Show 43 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ricardo Ruiz, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00389064     History of Changes
Other Study ID Numbers: D1448C00015, EUDRACT No: 2006-001195-21
Study First Received: October 17, 2006
Results First Received: April 15, 2009
Last Updated: March 30, 2012
Health Authority: Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:
Generalised Anxiety Disorder
GAD

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014