The Neurobiology of Depressive Illness
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2005 | ||||||||
| Last Updated Date | May 19, 2008 | ||||||||
| Start Date ICMJE | June 2000 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
level of sympathetic nervous system activity and its response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00168493 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
clinical response to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Neurobiology of Depressive Illness | ||||||||
| Official Title ICMJE | The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function | ||||||||
| 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Major Depression | ||||||||
| Intervention ICMJE | Drug: antidepressants primarily selective serotonin reuptake inhibitors
normal clinical dosages used according to clinical response as determined by a psychiatrist |
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| Study Arm (s) | Active Comparator: intervention
there is no sham or placebo control arm It is a single arm study
Intervention: Drug: antidepressants primarily selective serotonin reuptake inhibitors |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00168493 | ||||||||
| Other Study ID Numbers ICMJE | NHMRC D-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr David Barton, Baker Heart Research Institute | ||||||||
| Study Sponsor ICMJE | Baker Heart Research Institute | ||||||||
| Collaborators ICMJE | National Health and Medical Research Council, Australia | ||||||||
| Investigators ICMJE |
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| Information Provided By | Baker Heart Research Institute | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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