Phase 3
Completed N=450
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
Source: ClinicalTrials.gov NCT00389064 ↗Enrolled (actual)
450
Serious AEs
0.9%
Results posted
Jun 2009
Primary outcomePrimary: Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — -14.97; -7.21 units on scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
-14.97; -7.21 | — |
| SECONDARY Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score |
14.82; 4.94 | — |
| SECONDARY Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score |
-1.76; -0.59 | — |
| SECONDARY Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score |
-8.88; -3.81 | — |
| SECONDARY Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score |
-6.05; -3.37 | — |
| SECONDARY Hamilton Rating Scale for Anxiety (HAM-A) Response. |
152; 54 | — |
| SECONDARY Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission |
89; 29 | — |
| SECONDARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) |
-6.94; -2.22 | — |
| SECONDARY Change in the Visual Analogue Scale (VAS) Measuring Pain |
-17.95; -6.18 | — |
| SECONDARY Safety and Well Tolerated as Measured in Adverse Event |
145.00; 114.00 | — |
| SECONDARY Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) |
12.00; 5.00 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00389064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.