Beyond Aging Project 2015

Trial name or title	Beyond Ageing Project phase 2: a selective prevention trial using novel pharmacotherapies in an older age cohort at risk for depression
Methods	RCT
Participants	Older adults (60+ years) at risk of depression (K‐10 score ranging from 16‐29) who initially participated in the first Beyond Ageing Project
Interventions	Each for 12 months: Arm 1: omega‐3 (4 capsules, total 2 g/d: 1200 mg EPA and 800 mg DHA) and placebo microcrystalline cellulose (1 capsule) Arm 2: paraffin oil placebo (4 capsules) and sertraline hydrochloride (1 capsule, 50 mg) Arm 3: paraffin oil placebo (4 capsules) and placebo microcrystalline cellulose (1 capsule)
Outcomes	Primary: depressive symptoms (PHQ‐9, patient health questionnaire 9) Secondary: cognitive decline, MMSE, brain metabolism, hippocampal volume, anxiety (assessed using GAD‐7), disability (WHODAS‐II), sleeping problems (PSQI, Pittsburgh Sleep Quality Index), exercise (Active Australian Survey)
Starting date	Registered on trials registry: 12 January 2010 Study start date: June 2011 Estimated study completion date: main results expected in 2017
Contact information	Ian Hickie (PI), Brain and Mind Centre, University of Sydney, ian.hickie@sydney.adu.au
Notes	ACTRN12610000032055