The Neurobiology of Depressive Illness

Sponsor
Baker Heart Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT00168493
Collaborator
National Health and Medical Research Council, Australia (Other)
40
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114
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Study Details

Study Description

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
  • Drug: antidepressants primarily selective serotonin reuptake inhibitors
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2000
Anticipated Primary Completion Date :
Dec 1, 2008
Anticipated Study Completion Date :
Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. level of sympathetic nervous system activity and its response to treatment [12 weeks]

Secondary Outcome Measures

  1. clinical response to treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Major depression
Exclusion Criteria:
  • heart disease diabetes hypertension psychosis significant suicidal risk dementia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baker Heart Research Institute Melbourne Victoria Australia 3

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00168493
Other Study ID Numbers:
  • NHMRC D-01
First Posted:
Sep 15, 2005
Last Update Posted:
May 20, 2008
Last Verified:
May 1, 2008

Study Results

No Results Posted as of May 20, 2008