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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168493




Registration number
NCT00168493
Ethics application status
Date submitted
10/09/2005
Date registered
15/09/2005
Date last updated
20/05/2008

Titles & IDs
Public title
The Neurobiology of Depressive Illness
Scientific title
The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function
Secondary ID [1] 0 0
NHMRC D-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - antidepressants primarily selective serotonin reuptake inhibitors

Active Comparator: intervention - there is no sham or placebo control arm It is a single arm study


Treatment: Drugs: antidepressants primarily selective serotonin reuptake inhibitors
normal clinical dosages used according to clinical response as determined by a psychiatrist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
level of sympathetic nervous system activity and its response to treatment
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
clinical response to treatment
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
- Major depression
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- heart disease diabetes hypertension psychosis significant suicidal risk dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2009
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168493
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murray A Esler, MBBS Phd
Address 0 0
Baker Heart Research Insitute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David A Barton, MBBSFRANZCP
Address 0 0
Country 0 0
Phone 0 0
61393428946
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168493