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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No: 2006-001196-38 |
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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 depressive symptoms in elderly patients with major depressive disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. | MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value. | Baseline to Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) | Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life. | Baseline to Week 9 |
| Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Datto, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24816198 | Derived | Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624. | |
| 24175720 | Derived | Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520. |
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Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression
International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine XR | Quetiapine fumarate XR - flexibly dosed (50 - 300 mg) |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value |
| Baseline to Week 9 |
| Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) | Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety. | Baseline to Week 9 |
| Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0 | Baseline to Week 9 |
| Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 | The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0 | Baseline to Week 9 |
| Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) | The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0 | Baseline to Week 9 |
| Tolerability as Measured by Adverse Event Withdrawals During Treatment | Baseline to Week 9 |
| San Diego |
| California |
| United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Gainsville | 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 | Eugene | Oregon | United States |
| Research Site | Jenkintown | Pennsylvania | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | City Bell | Buenos Aires | Argentina |
| Research Site | La Plata | Buenos Aires | Argentina |
| Research Site | Córdoba | Córdoba Province | Argentina |
| Research Site | Mendoza | Mendoza Province | Argentina |
| Research Site | Buenos Aires | Argentina |
| Research Site | Capital Federal | Argentina |
| Research Site | Tartu | Estonia | Estonia |
| Research Site | Tallinn | Estonia |
| Research Site | Viljandi | Estonia |
| Research Site | Helsinki | Finland | Finland |
| Research Site | Tampere | Finland | Finland |
| Research Site | Jarvenpaa | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Salo | Finland |
| Research Site | Seinäjoki | Finland |
| 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 | Stavropol | Russia |
| Research Site | Hlevakha | Kyiv Oblast | 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 |
| 24162081 | Derived | Montgomery SA, Altamura AC, Katila H, Datto C, Szamosi J, Eriksson H. Efficacy of extended release quetiapine fumarate monotherapy in elderly patients with major depressive disorder: secondary analyses in subgroups of patients according to baseline anxiety, sleep disturbance, and pain levels. Int Clin Psychopharmacol. 2014 Mar;29(2):93-105. doi: 10.1097/YIC.0000000000000007. |
| 23639212 | Derived | Locklear JC, Svedsater H, Datto C, Endicott J. Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder. J Affect Disord. 2013 Jul;149(1-3):189-95. doi: 10.1016/j.jad.2013.01.021. Epub 2013 Apr 29. |
| 23567397 | Derived | Katila H, Mezhebovsky I, Mulroy A, Berggren L, Eriksson H, Earley W, Datto C. Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. Am J Geriatr Psychiatry. 2013 Aug;21(8):769-84. doi: 10.1016/j.jagp.2013.01.010. Epub 2013 Feb 6. |
| Completed Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine XR | Quetiapine fumarate XR - flexibly dosed (50 - 300 mg) |
| BG001 | Placebo | 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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| Region of Enrollment | Number | Participants |
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| DSM IV diagnosis | Number | 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 From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. | MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value. | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Least Squares Mean | Standard Deviation | units on scale | Baseline to Week 9 |
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| Secondary | Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) | Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life. | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Least Squares Mean | Standard Deviation | Percentage of Improvement | Baseline to Week 9 |
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| Secondary | Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) | Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated | Posted | Median | Full Range | units on scale | Baseline to Week 9 |
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| Secondary | Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) | Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety. | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline to Week 9 |
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| Secondary | Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0 | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Least Squares Mean | Standard Deviation | units on scale | Baseline to Week 9 |
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| Secondary | Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 | The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0 | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Median | Full Range | units on scale | Baseline to Week 9 |
|
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| Secondary | Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) | The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0 | All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. | Posted | Median | Full Range | units on scale | Baseline to Week 9 |
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| Secondary | Tolerability as Measured by Adverse Event Withdrawals During Treatment | All Randomized patients. | Posted | Number | Participants | Baseline to Week 9 |
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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 fumarate XR - flexibly dosed (50 - 300 mg) | 4 | 166 | 133 | 166 | ||
| EG001 | Placebo | Placebo | 2 | 172 | 54 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Depressive Symptom | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Suicide Attempt | Psychiatric 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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| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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The PI agrees to collaborate in good faith with AstraZeneca with regard 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 | |
|---|---|---|---|---|
| Medical Science Director, Seroquel | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
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| Male |
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| North America |
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| South America |
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| 296.3x - Major depressive disorder, recurrent |
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