Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiovascular Biomarkers During Quetiapine Treatment of Depression|
- Improvement in biomarkers of CV disease. Do patients with Major Depressive Disorder and co-morbid anxiety and increased platelet reactivity, endothelial dysfunction, and inflammation normalize these parameters following treatment with quetiapine. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Determine whether treatment with a low-dose quetiapine will alleviate symptoms of depression and anxiety. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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 (Seroquel-XR) 50-300mg daily for 12 weeks.
Other Name: Seroquel
The evidence that depressive and anxiety disorders confer a high relative risk (RR) for cardiovascular disease 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951483
|United States, Illinois|
|Loyola University Health System|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||John Piletz, PhD||Loyola University|