Objective: To examine the data on the effect of antidepressant medication in depressed children and adolescents and the causes of the results obtained.
Method: A systematic literature search was conducted, supplemented by a manual search, and a search of public online information on paediatric antidepressant trials reviewed by regulatory agencies.
Results: Data gathered from published and unpublished randomized controlled trials vary in their findings, with most of the studies showing a lack of efficacy characterized by a high placebo response rate.
Conclusion: Differences from efficacy results with the same drugs in adult depression may be because of neurobiological developmental correlates, developmental differences in pharmacokinetics and pharmacodynamics, high rates of placebo response in children, and a number of methodological influences. There are several areas needing more attention in paediatric antidepressant clinical trials. Judicious use of published and unpublished studies to assess who may benefit from treatment with antidepressants seems warranted.