title: Youth Depression Alleviation-Augmentation with an anti-inflammatory agent (YoDA-A): protocol and rationale for a placebo-controlled randomized trial of rosuvastatin and aspirin.
abstract: There is growing support for the role of inflammation and oxidative stress in the pathophysiology of major depressive disorder (MDD). This has led to the development of novel strategies targeting inflammation in the treatment of depression. Rosuvastatin and aspirin 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, aspirin and rosuvastatin experience a reduction in the severity of MDD compared with individuals receiving placebo.
  
  
  
  YoDA-A is a 12-week triple-blind, randomized controlled trial funded by the National Health and Medical Research Council, Australia. Participants aged 15-25, with moderate-to-severe MDD, are allocated to receive either 10 mg/day rosuvastatin, 100 mg/day aspirin, or placebo, in addition to treatment as usual. Participants are assessed at baseline and at weeks 4, 8, 12 and 26. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12.
  
  
  
  The study is planned to be completed in 2017. At date of publication, 85 participants have been recruited.
  
  
  
  Timely and targeted intervention for youth MDD is crucial. Given the paucity of new agents to treat youth MDD, 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 MDD; aspirin and rosuvastatin. Second, this study will serve as proof of principle of the role of inflammation in MDD.
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Amelia L
authors.initials: AL
authors.lastname: Quinn
authors.affiliation: Deakin University, IMPACT Strategic Research Centre, School of Medicine, University of Melbourne, Parkville, Australia.|Florey Institute for Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.|Department of Psychiatry, University of Melbourne, Parkville, Australia.|Barwon Health, Geelong, Australia.
authors.forename: Olivia M
authors.initials: OM
authors.lastname: Dean
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Christopher G
authors.identifier: 0000-0003-1431-3852
authors.initials: CG
authors.lastname: Davey
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Melissa
authors.initials: M
authors.lastname: Kerr
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Susy M
authors.initials: SM
authors.lastname: Harrigan
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Sue M
authors.initials: SM
authors.lastname: Cotton
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Chanen
authors.affiliation: Deakin University, IMPACT Strategic Research Centre, School of Medicine, University of Melbourne, Parkville, Australia.|Department of Psychiatry, University of Melbourne, Parkville, Australia.|Barwon Health, Geelong, Australia.
authors.forename: Seetal
authors.initials: S
authors.lastname: Dodd
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Aswin
authors.initials: A
authors.lastname: Ratheesh
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: G Paul
authors.initials: GP
authors.lastname: Amminger
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Phelan
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Amber
authors.initials: A
authors.lastname: Williams
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Mackinnon
authors.affiliation: Department of Psychiatry, University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giorlando
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Shelley
authors.initials: S
authors.lastname: Baird
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Rice
authors.affiliation: Barwon Health, Geelong, Australia.
authors.forename: Melissa
authors.initials: M
authors.lastname: O'Shea
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Miriam R
authors.initials: MR
authors.lastname: Schäfer
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Orygen Youth Health, Northwestern Mental Health, Melbourne, Australia.
authors.forename: Edward
authors.initials: E
authors.lastname: Mullen
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Sarah
authors.identifier: 0000-0003-2532-0142
authors.initials: S
authors.lastname: Hetrick
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
authors.forename: Patrick
authors.initials: P
authors.lastname: McGorry
authors.affiliation: Orygen, the National Centre of Excellence in Youth Mental Health, Melbourne, Australia.|Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.|Deakin University, IMPACT Strategic Research Centre, School of Medicine, University of Melbourne, Parkville, Australia.|Florey Institute for Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.|Department of Psychiatry, University of Melbourne, Parkville, Australia.|Barwon Health, Geelong, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D055815:Young Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D001315:Australia; D015415:Biomarkers / Q000097:blood; D003865:Major Depressive Disorder / Q000097:blood / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D000068718:Rosuvastatin Calcium / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin; D015415:Biomarkers; D000068718:Rosuvastatin Calcium
keywords: aspirin; depression; inflammation; rosuvastatin; youth