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

• 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 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.

• 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

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.