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The Neurobiology of Depressive Illness

NCT ID: NCT00168493

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depression

Keywords

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Major Depression Cardiac disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

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

Group Type ACTIVE_COMPARATOR

antidepressants primarily selective serotonin reuptake inhibitors

Intervention Type DRUG

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

Interventions

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antidepressants primarily selective serotonin reuptake inhibitors

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Major depression

Exclusion Criteria

* heart disease diabetes hypertension psychosis significant suicidal risk dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Baker Heart Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Baker Heart Research Institute

Principal Investigators

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Murray A Esler, MBBS Phd

Role: PRINCIPAL_INVESTIGATOR

Baker Heart Research Insitute

Locations

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Baker Heart Research Institute

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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David A Barton, MBBSFRANZCP

Role: CONTACT

Phone: 61393428946

Email: [email protected]

Murray Esler, PhD Fracp

Role: CONTACT

Phone: 61385321338

Email: [email protected]

Facility Contacts

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David A Barton, MBBS

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23627666 (View on PubMed)

Other Identifiers

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NHMRC D-01

Identifier Type: -

Identifier Source: org_study_id