Piperoglou 2014.

Study name	Adjunctive natural low dose docosahexaenoic acid (DHA) omega‐3 in a 16 week random double‐blind placebo controlled (RDBPC) cross‐over withdrawal study in a group of chronic, psychiatric out‐patients with anxiety and mood disorders
Methods	Randomised controlled, double‐blind, cross‐over trial Following the open‐label phase (first 4 weeks of the study) there will be 2 double‐blind cross‐over phases, each of 8 weeks duration, where the participant will first take DHA omega‐3 then look‐alike placebo capsule containing safflower oil, or placebo then DHA omega‐3. In the final 4 weeks phase all participants receive DHA omega‐3
Participants	Adults aged 20 ‐ 70 who are: 1. Outpatients with chronic anxiety and/or depressive symptoms 2. Patients currently taking DHA (NeuroSpark) capsules for at least 3 months prior to study entry
Interventions	Intervention: Natural low‐dose docosahexaenoic acid (DHA) omega‐3 (NeuroSpark) 130 ‐ 390 mg per day in addition to standard psychiatric treatments Comparator: safflower oil capsules Treatment given for 16 weeks
Outcomes	Primary: HAM‐A, HDRS, LSEQ, Fatigue questionnaire Secondary: Change from baseline in cognitive function; levels of metabolites of Arachidonic acid (AA); cytokines (e.g. TNF‐alpha and others), inflammatory markers (CRP), RBC membrane PUFA analyses to measure PUFA levels Measurements taken at weeks 0, 4, 12, 20 and 24 (various measures at each time point)
Starting date	May 2014
Contact information	Michael Piperoglou, University of Melbourne
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