Youth Depression Alleviation-Augmentation with an anti-inflammatory agent (YoDA-A): protocol and rationale for a placebo-controlled randomized trial of @entity8671 and XXXX .

@entity1 @entity32 @entity308 @entity117 @entity8671
AIM: There is growing support for the role of @entity32 and oxidative stress in the pathophysiology of @entity308 ( @entity308 ). This has led to the development of novel strategies targeting @entity32 in the treatment of @entity308 . @entity8671 and @entity117 have well-documented, anti-inflammatory and antioxidant properties. The aim of the Youth Depression Alleviation: Augmentation with an anti-inflammatory agent (YoDA-A) study is to determine whether individuals receiving adjunctive anti-inflammatory agents, @entity117 and @entity8671 experience a reduction in the severity of @entity308 compared with individuals receiving placebo. METHODS: YoDA-A is a 12-week triple-blind, randomized controlled trial funded by the National Health and Medical Research Council, Australia. @entity1 aged 15-25, with moderate-to-severe @entity308 , are allocated to receive either 10   mg/day @entity8671 , 100   mg/day @entity117 , or placebo, in addition to treatment as usual. @entity1 are assessed at baseline and at weeks 4, 8, 12 and 26. The primary outcome is change in the Montgomery-  sberg Depression Rating Scale (MADRS) from baseline to week 12. RESULTS: The study is planned to be completed in 2017. At date of publication, 85 @entity1 have been recruited. CONCLUSION: Timely and targeted intervention for youth @entity308 is crucial. Given the paucity of new agents to treat youth @entity308 , adjunctive trials are not only pragmatic and 'real-world', but additionally aim to target shortfalls in conventional medications. This study has the potential to first provide two new adjunctive treatment options for youth @entity308 ; @entity117 and @entity8671 . Second, this study will serve as proof of principle of the role of @entity32 in @entity308 .
