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The Neurobiology of Depressive Illness

B

Baker Heart Research Institute

Status

Unknown

Conditions

Major Depression

Treatments

Drug: antidepressants primarily selective serotonin reuptake inhibitors

Study type

Interventional

Funder types

Other

Identifiers

NCT00168493
NHMRC D-01

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Major depression

Exclusion criteria

  • heart disease diabetes hypertension psychosis significant suicidal risk dementia

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

intervention
Active Comparator group
Description:
there is no sham or placebo control arm It is a single arm study
Treatment:
Drug: antidepressants primarily selective serotonin reuptake inhibitors

Trial contacts and locations

1

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Central trial contact

Murray Esler, PhD Fracp; David A Barton, MBBSFRANZCP

Data sourced from clinicaltrials.gov

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