The Neurobiology of Depressive Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Baker Heart Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Baker Heart Research Institute
ClinicalTrials.gov Identifier:
NCT00168493
First received: September 10, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function

Resource links provided by NLM:


Further study details as provided by Baker Heart Research Institute:

Primary Outcome Measures:
  • level of sympathetic nervous system activity and its response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depression

Exclusion Criteria:

  • heart disease diabetes hypertension psychosis significant suicidal risk dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168493

Contacts
Contact: David A Barton, MBBSFRANZCP 61393428946 david.barton@bigpond.com
Contact: Murray Esler, PhD Fracp 61385321338 Murray.Esler@baker.edu.au

Locations
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         
Sponsors and Collaborators
Baker Heart Research Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Murray A Esler, MBBS Phd Baker Heart Research Insitute
  More Information

No publications provided by Baker Heart Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr David Barton, Baker Heart Research Institute
ClinicalTrials.gov Identifier: NCT00168493     History of Changes
Other Study ID Numbers: NHMRC D-01
Study First Received: September 10, 2005
Last Updated: May 19, 2008
Health Authority: Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014