A Phase 3 interventional study of Quetiapine XR and Placebo in Anxiety Disorders, sponsored by AstraZeneca. Completed at 43 sites in 5 countries. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2012-04-04.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 450 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
Drug: Quetiapine XR
Matching placebo tablets orally administered once daily.
Drug: Placebo
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.
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
Time frame: Randomization to Week 9
Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
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
Time frame: Randomization to Week 9
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
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
Time frame: Randomization to Week 9
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Time frame: Randomization to Week 9
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Time frame: Randomization to Week 9
Hamilton Rating Scale for Anxiety (HAM-A) Response.
HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Time frame: Week 9
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
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
Time frame: Week 9
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Time frame: Randomization to week 9
Change in the Visual Analogue Scale (VAS) Measuring Pain
Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Time frame: Randomization to week 9
Safety and Well Tolerated as Measured in Adverse Event
Number of patients have at least one adverse event
Time frame: From the start of treatment to last dose plus 30 days
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
Number of patients have adverse events associated with EPS
Time frame: From start of the study teatment to last dose plus 30 days
International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008
| Milestone | Quetiapine XR | Placebo |
|---|---|---|
| Started | 223 | 227 |
| Completed | 178 | 168 |
| Not completed | 45 | 59 |
| Withdrew: Adverse event | 11 | 3 |
| Withdrew: Lack of efficacy | 3 | 14 |
| Withdrew: Withdrawal by subject | 17 | 27 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Multiple reasons | 9 | 11 |
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
| units on scale | Quetiapine XR | Placebo |
|---|---|---|
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | -14.97 ± 7.4 | -7.21 ± 7.8 |
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
| Percentage of Maximum Total Score | Quetiapine XR | Placebo |
|---|---|---|
| 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 ± 12.40 | 4.94 ± 11.60 |
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
| units on scale | Quetiapine XR | Placebo |
|---|---|---|
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | -1.76 ± 1.10 | -0.59 ± 1.00 |
HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
| units on scale | Quetiapine XR | Placebo |
|---|---|---|
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | -8.88 ± 4.20 | -3.81 ± 4.60 |
HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
| units on scale | Quetiapine XR | Placebo |
|---|---|---|
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | -6.05 ± 4.00 | -3.37 ± 3.90 |
HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
| Number of participants. | Quetiapine XR | Placebo |
|---|---|---|
| Hamilton Rating Scale for Anxiety (HAM-A) Response. | 152 | 54 |
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
| Number of participants. | Quetiapine XR | Placebo |
|---|---|---|
| Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission | 89 | 29 |
MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
| units on scale | Quetiapine XR | Placebo |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | -6.94 ± 4.70 | -2.22 ± 4.70 |
Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
| mm | Quetiapine XR | Placebo |
|---|---|---|
| Change in the Visual Analogue Scale (VAS) Measuring Pain | -17.95 ± 21.80 | -6.18 ± 19.80 |
Number of patients have at least one adverse event
| Participants | Quetiapine XR | Placebo |
|---|---|---|
| Safety and Well Tolerated as Measured in Adverse Event | 145.00 | 114.00 |
Number of patients have adverse events associated with EPS
| Patients | Quetiapine XR | Placebo |
|---|---|---|
| Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) | 12.00 | 5.00 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quetiapine XR | — | 1/223 (0.4%) | 171/223 (76.7%) |
| Placebo | — | 3/227 (1.3%) | 89/227 (39.2%) |
| Event | Quetiapine XR | Placebo |
|---|---|---|
| BronchopneumoniaInfections and infestations | 1/223 | 0/227 |
| CardiomyopathyCardiac disorders | 0/223 | 1/227 |
| CellulitisInfections and infestations | 0/223 | 1/227 |
| CholelithiasisHepatobiliary disorders | 0/223 | 1/227 |
| Event | Quetiapine XR | Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 58/223 | 19/227 |
| Dry MouthGastrointestinal disorders | 37/223 | 16/227 |
| DizzinessNervous system disorders | 30/223 | 16/227 |
| HeadacheNervous system disorders | 26/223 | 29/227 |
| NauseaGastrointestinal disorders | 20/223 | 9/227 |
| Age, Customized(Participants) | Quetiapine XR | Placebo | Total |
|---|---|---|---|
| 66 to 75 years | 197 | 195 | 392 |
| > 75 years | 26 | 32 | 58 |
| Sex: Female, Male(Participants) | Quetiapine XR | Placebo | Total |
|---|---|---|---|
| Female | 161 | 157 | 318 |
| Male | 62 | 70 | 132 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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