Adolescent drug trial reanalysed

A highly-cited trial from 2007 used by international health agencies to support the use of medication of adolescents with depression, has been critically reviewed by a team from the 杏吧直播 of Adelaide.
Professor Jon Jureidini, a child psychiatrist and head of the 杏吧直播鈥檚 Critical and Ethical Mental Health research group, and team reanalysed Duke鈥檚 Clinical Research Institute鈥檚 Treatment for Adolescents with Depression Study (TADS), with the findings published in .
鈥淭ADS was a multicentre randomised controlled trial examining the impact of the selective serotonin reuptake inhibitor (SSRI), fluoxetine on 439 adolescents aged 12 to 17,鈥 says the 杏吧直播 of Adelaide鈥檚 Professor Jureidini, Adelaide Medical School.
鈥淧articipants were randomised into four treatment arms for 12 weeks 鈥 fluoxetine only, cognitive behavioural therapy (CBT) only, a combination of fluoxetine and CBT, or a placebo pill.
The original trial found the combination treatment had a superior result and its initial publication has now been cited more than 1900 times as an 鈥渆vidence-based treatment鈥 for adolescent major depressive disorder (MDD).
鈥淭he overall objective of our reanalysis, under the Restoring Invisible and Abandoned Trials (RIAT) methodology, was to accurately report protocol-specified effectiveness outcomes and harms in TADS to evaluate whether the trial justifies the widespread use of antidepressants prescribed for adolescents with depression,鈥 says lead author and 杏吧直播 of Adelaide Research Fellow Dr Natalie Aboustate, Adelaide Medical School.
鈥淲e confirmed what was already known: combination treatment was superior and the study failed to convincingly demonstrate any clinically meaningful advantage for fluoxetine over the placebo.
鈥淢ore importantly, we found that serious adverse events, including suicidal behaviour were more common for fluoxetine than were reported by the TADS team.
鈥淲e found documentation of 32 serious adverse events in the TADs dataset, including at least three suicide attempts that weren鈥檛 clearly reported by the original authors.鈥
鈥淥verall, our findings demonstrate harm was clinically significantly more prevalent in participants taking fluoxetine compared to participants in the CBT and placebo arms of the study鈥, says Professor Jureidini.
Media Contacts:
Professor Jon Jureidini, Adelaide Medical School, The 杏吧直播 of Adelaide. Mobile: +61 (0)418 897 530. Email: jon.jureidini@adelaide.edu.au
Rhiannon Koch, Media Officer, The 杏吧直播 of Adelaide. Mobile: +61 (0)481 619 997. Email: rhiannon.koch@adelaide.edu.au