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No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular disease risk associated with depression and anxiety. The purpose of this study is to determine if quetiapine treatment of depression can reverse the signs of arterial stiffening that often occurs in depression and anxiety, and which are believed to be risk factors for future heart disease.
The evidence that depressive and anxiety disorders confer a high relative risk (RR) for cardiovascular disease (CVD) development is clear and compelling. A cadre of inflammation, platelet activation and other biomarkers of endothelial dysfunction strongly suggest multiple and possibly interrelated mechanisms underlying this co-morbidity. Early detection of the vulnerability to develop CVD has become an urgent health issue. However, detection alone of vulnerability without proper therapeutic intervention aimed at reversing it, is merely of scientific interest. The evidence to date that antidepressant drugs, while highly efficacious in restoring euthymia, may not normalize the biomarkers of CVD vulnerability. Hence, there is a need to identify other pharmacologic interventions for depression. Quetiapine, due to its unique molecular structure and unique pharmacological profile, belongs to none of the known classes of antidepressants. However, quetiapine clearly has antidepressant and anti-anxiety efficacies. Now, we propose to explore whether quetiapine can reverse those pathophysiological changes occurring in mixed depression/anxiety that have been linked causally to the development of CVD. Accordingly, the primary purpose of this study is to compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Cohort | Experimental | Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. |
|
| Healthy Control | No Intervention | Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine-XR | Drug | Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive Protein at 12 Weeks | To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7) | The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood. | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant, lactating, breast feeding or on oral contraceptives
Any DSM-IV Axis I disorder not defined in the inclusion criteria except MDD co-morbid with generalized anxiety disorder (GAD)
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Known intolerance or lack of response to quetiapine (Seroquel) as judged by the investigator
Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
Concomitant use of any other antidepressant, anxiolytic, or antipsychotic agent
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before the study begins
Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
History of heavy smoking within the preceding 6 months
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Restrictions prior to blood drawings: Aspirin (previous 240 hours), antihistamines (previous 72 hours), Tylenol (previous 72 hours), Vitamin C or E (previous 72 hours), sleeping pills (previous 72 hours), caffeinated beverages (8 hours), physical exertion (8 hours) and tobacco products (2 hours).
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
Involvement in the planning and conduct of the study
Previous enrolment in the present study.
Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelos Halaris, MD, PhD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Health System | Maywood | Illinois | 60153 | United States |
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Ninety-one individuals were consented and 47 participants received study drug while 44 participants enrolled as healthy control participants between July 2009 and October 2011. Participants were recruited using physician solicitation and advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Cohort | Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks. |
| FG001 | Healthy Control | Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis were conducted on all individuals who signed an informed consent document (N = 91)
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Cohort | Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | C-Reactive Protein at 12 Weeks | To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment. | Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40). | Posted | Median | Inter-Quartile Range | mg/L | 12 weeks |
|
Adverse event data were collected during the 12 Week trial.
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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 | Experimental Cohort | Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks. Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight gain | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angelos Halaris, MD, PhD | Loyola University Chicago | 708-216-3275 | ahalaris@lumc.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17) |
The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. |
| Baseline and 12 weeks |
| Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21) | The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. | Baseline and 12 weeks |
| Change in Hamilton Rating Scale for Anxiety (HAM-A) | The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety. | Baseline and 12 weeks |
| Change in Beck Depression Inventory (BDI) | The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood. | Baseline and 12 weeks |
| Change in 14-item Perceived Stress Scale (PSS-14) | The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress. | Baseline and 12 weeks |
| BG001 | Healthy Control | Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Tobacco Use | Number | Participants |
|
| Height | Height was measured in meters | Mean | Standard Deviation | Meters |
|
| Weight | Weight was measured in kilograms | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Menopausal Status | Number | participants |
|
| Family History of Depression | Number | participants |
|
| Concomitant Psychiatric Medication | Number | participants |
|
| Family History of Alzheimer's Disease | Number | participants |
|
| Baseline Hamilton Rating Scale for Depression with Seven Items | The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Hamilton Rating Scale for Depression with 17 Items | The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Hamilton Rating Scale for Depression with 21 Items | The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Hamilton Rating Scale for Anxiety | The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Beck Depression Inventory | The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood. | Median | Inter-Quartile Range | units on a scale |
|
| Perceived Stress Scale with 14 Items | The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress. | Median | Inter-Quartile Range | units on a scale |
|
Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks. |
|
|
|
| Secondary | Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7) | The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood. | This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17) | The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. | This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21) | The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. | This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
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|
|
| Secondary | Change in Hamilton Rating Scale for Anxiety (HAM-A) | The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety. | This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
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|
|
| Secondary | Change in Beck Depression Inventory (BDI) | The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood. | This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
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|
|
| Secondary | Change in 14-item Perceived Stress Scale (PSS-14) | The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress. | This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
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|
| 0 |
| 47 |
| 39 |
| 47 |
| EG001 | Healthy Control | Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks. | 0 | 44 | 0 | 44 |
| Fatigue | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Drowsiness | General disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased appetite | General disorders | Non-systematic Assessment |
|
| Increased irritability | General disorders | Non-systematic Assessment |
|
| Increased anxiety | Psychiatric disorders | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |