Abstract
BackgroundThe 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/DesignYoDA-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.Trial registrationAustralian and New Zealand Clinical Trials Registry ID: ACTRN12612001281886 (registered on 11 December 2012)
Highlights
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
In a recent Cochrane review [13], which included trials of all selective serotonin reuptake inhibitors (SSRIs) and newer classes of antidepressants, the authors confirmed that the effects of antidepressant medications for youth depression were small but significant, with rates of remission increasing from 380 per 1,000 for placebo to 448 per 1,000 for medication
Other evidence suggests that the difference is likely to be artefactual. In their recent Cochrane review [13], the authors implemented subgroup analysis to robustly investigate whether the effects of medication were modified by the type of antidepressant. They found no evidence for this hypothesis and concluded that it was premature to assert that fluoxetine is the most effective antidepressant for adolescent depression—especially given that there have been no head-to-head trials
Summary
Mental illnesses are the ‘chronic diseases of the young’ [1], and the mental illness that causes most disability in young people is major depressive disorder (MDD) [2]. In a subsequent meta-analysis, Bridge and colleagues [12] reached similar conclusions They reported a mean effect size of 0.25 (95% CI, 0.16 to 0.34) for antidepressant medications compared with placebo in the treatment of child and adolescent depression, with the fluoxetine trials showing an almost twofold greater effect size of 0.46 (95% CI, 0.29 to 0.62) [12]. In a number of small studies, researchers have compared combined treatment with therapy alone for comorbid depression and substance use disorders and have largely found no difference between these treatment approaches [39,40,41,42], Riggs and colleagues [40] observed an improvement in the group treated with CBT and fluoxetine on one depression measure, but not on another (and no difference in substance use outcomes).
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