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BMJ Open. 2019 Mar 15;9(3):e026089. doi: 10.1136/bmjopen-2018-026089.

Critical appraisal of adverse effects reporting in the 'Treatment for Adolescents With Depression Study (TADS)'.

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Regional Medicines Information and Pharmacovigilance Centre (RELIS Sør-Øst), Department of Pharmacology, Oslo University Hospital, Oslo, Norway.
Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway.
Department of Pharmacology, University of Oslo, Oslo, Norway.



To identify all publications from the 'Treatment for Adolescents With Depression Study (TADS)' and assess the findings regarding occurrence of any adverse effects in the treatment groups both for the short-term and long-term study stages.


Descriptive analysis of TADS publications with any information on adverse effects.


We identified 48 publications describing various aspects of the TADS, in which 439 adolescent patients received treatment with fluoxetine, cognitive-behavioural therapy, cognitive-behavioural therapy plus fluoxetine or placebo. Eight publications were assessed as providing some data on adverse effects. Risk of suicidal behaviour was the only adverse effect that was addressed in all publications. Several psychiatric and physical adverse effects were reported during the first 12 weeks, but not mentioned in reports from later study stages. Common adverse effects of fluoxetine, such as weight changes or sexual problems, were not identified or mentioned in the publications.


The TADS publications do not present a comprehensive assessment of treatment risk with fluoxetine in adolescents, especially for more than 12 weeks of treatment. Risk of suicidality was the only adverse effect that was reported over time. Reporting of adverse effects was incomplete with regard to the long-term safety profile of fluoxetine.


adverse events; clinical pharmacology; clinical trials

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