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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function
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Secondary ID [1]
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NHMRC D-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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level of sympathetic nervous system activity and its response to treatment
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Assessment method [1]
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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clinical response to treatment
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Assessment method [1]
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Timepoint [1]
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12 weeks
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Eligibility
Key inclusion criteria
* Major depression
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* heart disease diabetes hypertension psychosis significant suicidal risk dementia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2009
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart Research Institute - Melbourne
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Recruitment postcode(s) [1]
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3 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00168493
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Murray A Esler, MBBS Phd
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Address
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Baker Heart Research Insitute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David A Barton, MBBSFRANZCP
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Address
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Country
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Phone
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61393428946
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00168493
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