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Sponsors and Collaborators: |
Baker Heart Research Institute National Health and Medical Research Council, Australia |
Information provided by: | Baker Heart Research Institute |
ClinicalTrials.gov Identifier: | NCT00168493 |
We aim to determine why patients with depression are at an elevated risk for the development of coronary heart disease, and resolve whether the severity of a patient's depression has a counterpart in demonstrable abnormalities in brain chemistry. Studies will be completed in 28 patients with depression; both males and females. Patients will be studied both untreated and during administration of a selective serotonin re-uptake inhibitor (SSRI) antidepressant. They will be either newly diagnosed with depression, untreated patients suffering a recent relapse, or patients seeking to switch from a non-SSRI antidepressant due to non-response. The turnover of chemical messengers in the brain will be estimated by high internal jugular venous blood sampling and DNA will be isolated and examined from blood cells. Immune function will also be assessed. Whole body and cardiac sympathetic nervous activity will be determined, as well as microneurographic recording of muscle sympathetic nervous activity.
It is hypothesised that patients with depression and no existing demonstrable cardiac disease demonstrate:
Alterations in brain monoaminergic neurotransmitter turnover, resulting in sympathetic nervous activation and dysregulation of the baroreflex control to both the heart (vagal) and muscle vasoconstrictor sympathetic nerves; and Exhibit enhanced platelet reactivity predisposing them to thrombogenesis and myocardial ischaemia.
Therapeutic intervention with an SSRI will modify cardiac sympathetic function, baroreflex sensitivity or platelet reactivity in a fashion likely to reduce cardiac risk.
Condition | Intervention |
Major Depression |
Drug: antidepressants primarily selective serotonin reuptake inhibitors |
MedlinePlus related topics: | Antidepressants Depression Heart Disease in Women Heart Diseases |
ChemIDplus related topics: | Serotonin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function |
Estimated Enrollment: | 40 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
intervention: Active Comparator
there is no sham or placebo control arm It is a single arm study
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Drug: antidepressants primarily selective serotonin reuptake inhibitors
normal clinical dosages used according to clinical response as determined by a psychiatrist
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David A Barton, MBBSFRANZCP | 61393428946 | david.barton@bigpond.com |
Contact: Murray Esler, PhD Fracp | 61385321338 | Murray.Esler@baker.edu.au |
Australia, Victoria | |||||
Baker Heart Research Institute | Recruiting | ||||
Melbourne, Victoria, Australia, 3 | |||||
Contact: David A Barton, MBBS 61393428946 david.barton@bigpond.com | |||||
Principal Investigator: David a Barton, m |
Baker Heart Research Institute |
National Health and Medical Research Council, Australia |
Principal Investigator: | Murray A Esler, MBBS Phd | Baker Heart Research Insitute |
Responsible Party: | Baker Heart Research Institute ( Dr David Barton ) |
Study ID Numbers: | NHMRC D-01 |
First Received: | September 10, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00168493 |
Health Authority: | Australia: National Health and Medical Research Council |
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