title: The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial.
abstract: BACKGROUND
  The aim of the Youth Depression Alleviation-Combined Treatment (YoDA-C) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy. Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned, and subsequent treatment guidelines for youth depression have provided only qualified support.
  
  
  METHODS
  YoDA-C is a double-blind, randomised controlled trial funded by the Australian government's National Health and Medical Research Council. Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either (1) cognitive behavioural therapy (CBT) and fluoxetine or (2) CBT and placebo. The treatment duration will be 12 weeks, and follow-up will be conducted at 26 weeks. The primary outcome measure is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) after 12 weeks of treatment. The MADRS will be administered at baseline and at weeks 4, 8, 12 and 26. Secondary outcome measures will address additional clinical outcomes, functioning, quality of life and safety.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012).
authors.affiliation: Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Road, Parkville, VIC 3052, Australia. c.davey@unimelb.edu.au.
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Davey
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Chanen
authors.forename: Sue M
authors.initials: SM
authors.lastname: Cotton
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Hetrick
authors.forename: Melissa J
authors.initials: MJ
authors.lastname: Kerr
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.forename: Olivia M
authors.initials: OM
authors.lastname: Dean
authors.forename: Kally
authors.initials: K
authors.lastname: Yuen
authors.forename: Mark
authors.initials: M
authors.lastname: Phelan
authors.forename: Aswin
authors.initials: A
authors.lastname: Ratheesh
authors.forename: Miriam R
authors.initials: MR
authors.lastname: Schäfer
authors.forename: G Paul
authors.initials: GP
authors.lastname: Amminger
authors.forename: Alexandra G
authors.initials: AG
authors.lastname: Parker
authors.forename: Danijela
authors.initials: D
authors.lastname: Piskulic
authors.forename: Susy
authors.initials: S
authors.lastname: Harrigan
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Mackinnon
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Harrison
authors.forename: Patrick D
authors.initials: PD
authors.lastname: McGorry
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000187:drug effects*; D000328:Adult; D000367:Age Factors; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014739:Victoria; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors