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| Sponsor: | Loyola University |
|---|---|
| Information provided by: | Loyola University |
| ClinicalTrials.gov Identifier: | NCT00951483 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Anxiety |
Drug: Quetiapine-XR |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | Cardiovascular Biomarkers During Quetiapine Treatment of Depression |
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: 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.
|
Drug: Quetiapine-XR
Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
Contacts and Locations| Contact: John Piletz, PhD | 708-216-5090 | jpiletz@lumc.edu |
| United States, Illinois | |
| Loyola University Health System | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Sub-Investigator: Angelos Halaris, MD, PhD | |
| Principal Investigator: | John Piletz, PhD | Loyola University |
More Information
| Responsible Party: | Loyola University Medical Center ( John Piletz, PhD ) |
| Study ID Numbers: | 201880 |
| Study First Received: | July 31, 2009 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00951483 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cardiovascular Biomarkers Depression Quetiapine |
|
Depression Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Depressive Disorder Antipsychotic Agents |
Pharmacologic Actions Behavioral Symptoms Quetiapine Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |