The Neurobiology of Depressive Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00168493
Recruitment Status : Unknown
Verified May 2008 by Baker Heart Research Institute.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : May 20, 2008
National Health and Medical Research Council, Australia
Information provided by:
Baker Heart Research Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Major Depression Drug: antidepressants primarily selective serotonin reuptake inhibitors Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function
Study Start Date : June 2000
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
Active Comparator: intervention
there is no sham or placebo control arm It is a single arm study
Drug: antidepressants primarily selective serotonin reuptake inhibitors
normal clinical dosages used according to clinical response as determined by a psychiatrist

Primary Outcome Measures :
  1. level of sympathetic nervous system activity and its response to treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. clinical response to treatment [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major depression

Exclusion Criteria:

  • heart disease diabetes hypertension psychosis significant suicidal risk dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00168493

Contact: David A Barton, MBBSFRANZCP 61393428946
Contact: Murray Esler, PhD Fracp 61385321338

Australia, Victoria
Baker Heart Research Institute Recruiting
Melbourne, Victoria, Australia, 3
Contact: David A Barton, MBBS    61393428946   
Principal Investigator: David a Barton, m         
Sponsors and Collaborators
Baker Heart Research Institute
National Health and Medical Research Council, Australia
Principal Investigator: Murray A Esler, MBBS Phd Baker Heart Research Insitute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr David Barton, Baker Heart Research Institute Identifier: NCT00168493     History of Changes
Other Study ID Numbers: NHMRC D-01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Baker Heart Research Institute:
Major Depression
Cardiac disease

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Serotonin Uptake Inhibitors
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators