Back to resultsCardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quetiapine-XR
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Cardiovascular Biomarkers, Depression, Quetiapine
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of Major Depressive Disorder (MDD), first episode or recurrent, by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) requiring treatment. The index episode must be at least 14 days of persistent symptoms. If first episode, patients must not have been previously treated. If recurrent, must not be receiving treatment for the recurrence.
- Females and males 20-65 years of age
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at time of enrolment
- Able to understand and comply with the requirements of the study
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:
- Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- Not under physician care for DM
- Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
- Physician responsible for patient's DM care has not approved patient's participation in the study
Sites / Locations
- Loyola University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Cohort
Healthy Control
Arm Description
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.
Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention.
Outcomes
Primary Outcome Measures
C-Reactive Protein at 12 Weeks
To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00951483
Brief Title
Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
Official Title
Cardiovascular Biomarkers During Quetiapine Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Cardiovascular Biomarkers, Depression, Quetiapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention.
Intervention Type
Drug
Intervention Name(s)
Quetiapine-XR
Other Intervention Name(s)
Seroquel
Intervention Description
Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.
Primary Outcome Measure Information:
Title
C-Reactive Protein at 12 Weeks
Description
To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Hamilton Rating Scale for Anxiety (HAM-A)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in Beck Depression Inventory (BDI)
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change in 14-item Perceived Stress Scale (PSS-14)
Description
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.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A diagnosis of Major Depressive Disorder (MDD), first episode or recurrent, by Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) requiring treatment. The index episode must be at least 14 days of persistent symptoms. If first episode, patients must not have been previously treated. If recurrent, must not be receiving treatment for the recurrence.
Females and males 20-65 years of age
Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at time of enrolment
Able to understand and comply with the requirements of the study
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:
Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
Not under physician care for DM
Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
Physician responsible for patient's DM care has not approved patient's participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelos Halaris, MD, PhD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Health System
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
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