The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): Study protocol for a randomised control trial

Christopher G. Davey, Andrew M. Chanen, Sue M. Cotton, Sarah E. Hetrick, Melissa J. Kerr, Michael Berk, Olivia M. Dean, Kally Yuen, Mark Phelan, Aswin Ratheesh, Miriam R. Schäfer, G. Paul Amminger, Alexandra G. Parker, Danijela Piskulic, Susy Harrigan, Andrew J. Mackinnon, Ben J. Harrison, Patrick D. McGorry

Research output: Contribution to journalArticleOtherpeer-review

8 Citations (Scopus)

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/Design: 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.

Original languageEnglish
Article number425
Number of pages9
JournalTrials
Volume15
Issue number1
DOIs
Publication statusPublished - 4 Nov 2014
Externally publishedYes

Keywords

  • Adolescence
  • Antidepressants
  • Cognitive behavioural therapy
  • Depression
  • Fluoxetine
  • Selective serotonin reuptake inhibitors
  • Youth

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