Davey Christopher G, Chanen Andrew M, Cotton Sue M, Hetrick Sarah E, Kerr Melissa J, Berk Michael, Dean Olivia M, Yuen Kally, Phelan Mark, Ratheesh Aswin, Schäfer Miriam R, Amminger G Paul, Parker Alexandra G, Piskulic Danijela, Harrigan Susy, Mackinnon Andrew J, Harrison Ben J, McGorry Patrick D
Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Road, Parkville, VIC 3052, Australia.
Trials. 2014 Nov 4;15:425. doi: 10.1186/1745-6215-15-425.
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.
Australian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012).
青少年抑郁症联合治疗（YoDA-C）研究的目的是确定抗抑郁药物是否应作为青少年抑郁症一线治疗方案与心理治疗同时启动。荟萃分析对药物使用提出了质疑，其中抗抑郁药在年轻人中的疗效和安全性受到质疑，随后的青少年抑郁症治疗指南仅提供了有限的支持。
方法/设计：YoDA-C是一项由澳大利亚政府国家卫生与医学研究委员会资助的双盲随机对照试验。年龄在15至25岁之间、患有中度至重度重度抑郁症的参与者将被随机分配接受以下治疗之一：（1）认知行为疗法（CBT）和氟西汀，或（2）CBT和安慰剂。治疗期为12周，随访将在26周时进行。主要结局指标是治疗12周后蒙哥马利-Åsberg抑郁量表（MADRS）的变化。MADRS将在基线以及第4、8、12和26周时进行测量。次要结局指标将涉及其他临床结局、功能、生活质量和安全性。
澳大利亚和新西兰临床试验注册中心编号：ACTRN12612001281886（于2012年12月11日注册）。
