Phase 3
N=409
Generalized Anxiety Disorder Adjunct Study
Anxiety · Anxiety Disorders · Anxiety Neuroses · Anxiety States
Bottom Line
View on ClinicalTrials.gov: NCT00534599 ↗Enrolled (actual)
409
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score — -10.74; -9.61 units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); quetiapine fumarate XR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
-10.74; -9.61 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score |
-1.36; -1.13 | — |
| SECONDARY Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 |
114; 97 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score |
-6.09; -5.21 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score |
-4.63; -4.38 | — |
| SECONDARY Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 |
84; 72 | — |
| SECONDARY Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 |
48; 34 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score |
7.33; 6.43 | — |
| SECONDARY Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score |
0.30; 0.40 | — |
| SECONDARY Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score |
0.30; 0.20 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score |
-6.45; -4.47 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score |
-3.70; -2.46 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score |
-2.74; -2.0 | — |
| SECONDARY Least Square Mean Change From Randomization to Week 1 in CGI-S Score |
-0.56; -0.35 | — |
| SECONDARY Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 |
33; 22 | — |
Summary
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
Eligibility Criteria
Inclusion Criteria
Provision of Informed Consent
- Documented diagnosis of Generalized Anxiety Disorder
- Female patients must not be pregnant and be willing to use a reliable method of birth control
- Be able to understand and comply with study requirements
Exclusion Criteria
Other psychiatric disorders that could confound the study results, as judged by the study doctor
- Moderate to severe depression
- Other clinically relevant diseases, as judged by the study doctor
- Medication that you are taking, as judged by the study doctor
Data sourced from ClinicalTrials.gov (NCT00534599). 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.