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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No: 2006-001195-21 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetapine XR | Experimental | Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily. |
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| Placebo | Placebo Comparator | Matching placebo tablets orally administered once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine XR | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Randomization to Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Ruiz, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fort Myers | Florida | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23070803 | Derived | Mezhebovsky I, Magi K, She F, Datto C, Eriksson H. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013 Jun;28(6):615-25. doi: 10.1002/gps.3867. Epub 2012 Oct 16. |
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Screening for eligibility and wash-out of restriced medications
International multi-center study, 47 sites recruited between Sept 2006 and Apr 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine XR | Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period. |
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| 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 | 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 | 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 | 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. | 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:
| 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 | 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 | Randomization to week 9 |
| Safety and Well Tolerated as Measured in Adverse Event | Number of patients have at least one adverse event | 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 | From start of the study teatment to last dose plus 30 days |
| Gainsville |
| Florida |
| United States |
| Research Site | Miami | Florida | United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | Roswell | Georgia | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Avon Lake | Ohio | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Jenkintown | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Tartu | Estonia | Estonia |
| Research Site | Tallinn | Estonia |
| Research Site | Viljandi | Estonia |
| Research Site | Bialystok | Poland |
| Research Site | Gorlice | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Leszno | Poland |
| Research Site | Skorzewo | Poland |
| Research Site | Torun | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Arkhangelsk | Russia |
| Research Site | Izhevsk | Russia |
| Research Site | Lipetsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Nizhny Novgorod | Russia |
| Research Site | Perm | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Saratov | Russia |
| Research Site | Stavropol | Russia |
| Research Site | Voronezh | Russia |
| Research Site | Hlevakha | Kyiv Oblast | Ukraine |
| Research Site | Dnipro | Ukraine |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Luhansk | Ukraine |
| Research Site | Odesa | Ukraine |
| Research Site | Vinnitsa | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine XR | Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | units on scale | Randomization to Week 9 |
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| 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 | 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 | In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo). | Posted | Least Squares Mean | Standard Deviation | Percentage of Maximum Total Score | Randomization to Week 9 |
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| Secondary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | units on scale | Randomization to Week 9 |
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| Secondary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | units on scale | Randomization to Week 9 |
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| Secondary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | units on scale | Randomization to Week 9 |
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| Secondary | Hamilton Rating Scale for Anxiety (HAM-A) Response. | HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score. | Posted | Number | Number of participants. | Week 9 |
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| Secondary | 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:
| Modified Intent to Treat (MITT) population. | Posted | Number | Number of participants. | Week 9 |
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| Secondary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | units on scale | Randomization to week 9 |
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| Secondary | 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 | Modified Intent to Treat (MITT) population. | Posted | Least Squares Mean | Standard Deviation | mm | Randomization to week 9 |
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| Secondary | Safety and Well Tolerated as Measured in Adverse Event | Number of patients have at least one adverse event | Safety population | Posted | Number | Participants | From the start of treatment to last dose plus 30 days |
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| Secondary | Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) | Number of patients have adverse events associated with EPS | Safety population | Posted | Number | Patients | From start of the study teatment to last dose plus 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine XR | Quetiapine fumerate XR - flexibly dosed (50 - 300 mg) | 1 | 223 | 171 | 223 | ||
| EG001 | Placebo | 3 | 227 | 89 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Title | Measurements |
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| Male |
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