The Neurobiology of Depressive Illness

NCT00168493 | Unknown

• 1 other identifier: NHMRC D-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Major Depression; Cardiac disease

Outcome Measures

Primary Outcomes (1)

• level of sympathetic nervous system activity and its response to treatment

  12 weeks

Secondary Outcomes (1)

• clinical response to treatment

  12 weeks

Study Arms (1)

intervention

ACTIVE COMPARATOR

there is no sham or placebo control arm It is a single arm study

Drug: antidepressants primarily selective serotonin reuptake inhibitors

Interventions

antidepressants primarily selective serotonin reuptake inhibitors DRUG

normal clinical dosages used according to clinical response as determined by a psychiatrist

intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression

You may not qualify if:

• heart disease diabetes hypertension psychosis significant suicidal risk dementia

Sponsors & Collaborators

• Baker Heart Research Institute: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Baker Heart Research Institute

Melbourne, Victoria, 3, Australia

RECRUITING

Related Publications (1)

• Keating C, Dawood T, Barton DA, Lambert GW, Tilbrook AJ. Effects of selective serotonin reuptake inhibitor treatment on plasma oxytocin and cortisol in major depressive disorder. BMC Psychiatry. 2013 Apr 29;13:124. doi: 10.1186/1471-244X-13-124.

  PMID: 23627666 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Heart Diseases

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cardiovascular Diseases

Study Officials

• Murray A Esler, MBBS Phd

  Baker Heart Research Insitute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Barton, MBBSFRANZCP

CONTACT

61393428946; david.barton@bigpond.com

Murray Esler, PhD Fracp

CONTACT

61385321338; Murray.Esler@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2000
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

AU (1)