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document
The Beyond Ageing Project Phase 2 -- a double-blind , selective prevention , randomised , placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression : study protocol for a randomized controlled trial . BACKGROUND Late-life depression is associated with high rates of morbidity , premature mortality , disability , functional decline , caregiver burden and increased health care costs . While clinical and public health approaches are focused on prevention or early intervention strategies , the ideal method of intervention remains unclear . No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression . METHODS/DESIGN Subjects with previously reported sub-threshold depressive symptoms , aged 60 to 74 years , will be screened to participate in a single-centre , double-blind , randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride , compared with matching placebo . Subjects will be excluded if they have current depression or suicide ideation ; are taking antidepressants or any supplement containing omega-3 fatty acid ; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease , neurological disease , significant psychiatric disease ( other than depression ) or neurodegenerative disease . The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events . At three months , subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes . Additionally , proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions . The trial will be conducted in urban New South Wales , Australia , and will recruit a community-based sample of 450 adults . Using intention-to-treat methods , the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition . DISCUSSION The current health , social and economic costs of late-life depression make prevention imperative from a public health perspective . This innovative trial aims to address the long-neglected area of prevention of depression in older adults . The interventions are targeted to the pathophysiology of disease , and regardless of the effect size of treatment , the outcomes will offer major scientific advances regarding the neurobiological action of these agents . The main results are expected to be available in 2017 . TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 ( 12 January 2010 ) .
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Intervention_Pharmacological
omega-3 fatty acids
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Intervention_Pharmacological
sertraline
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Intervention_Pharmacological
omega-3 fatty acid supplementation
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Intervention_Pharmacological
sertraline hydrochloride
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Intervention_Control
placebo
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Outcome_Mortality
morbidity
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Outcome_Mortality
premature mortality
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Outcome_Physical
disability , functional decline
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Outcome_Other
caregiver burden
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Outcome_Other
health care costs
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Outcome_Other
structural neuroimaging
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Outcome_Other
proton spectroscopy
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Outcome_Other
brain-imaging markers
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Outcome_Physical
health
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Outcome_Other
social and economic costs