Prozac no better than placebo' for treating children with depression, experts say

"Clinical guidelines should no longer recommend Prozac for children, according to experts, after research showed it had no clinical benefit for treating depression in children and adolescents. Globally one in seven 10-19 year olds have a mental health condition, according to the World Health Organization. In the UK, about a quarter of older teenagers and up to a fifth of younger children have anxiety, depression or other mental health problems."

"In the UK, National Institute for Health and Care Excellence (Nice) guidance says under-18s with moderate to severe depression can be prescribed antidepressants alongside therapy. But a new review of trial data by academics in Austria and the UK concluded that fluoxetine, sold under the brand name of Prozac among others, is clinically no better than placebo drugs in treating depression in children, and should therefore no longer be prescribed to them."

"The authors conducted a meta analysis of 12 large trials involving Prozac, published between 1997 and 2024, and concluded that fluoxetine improved children's depressive symptoms so little as to not be considered clinically meaningful. Consider the analogy of a weight-loss drug that is better than placebo at producing weight loss, but the difference is only 100 grams, said Martin Ploderl, a clinical psychologist at Paracelsus Medical University in Salzburg, Austria, and lead author of the study."

"The study, published in the Journal of Clinical Epidemiology, identified a novelty bias in early trials, which were likely to be more positive, while later studies fail to confirm these effects. It concludes that the potential risks of harmful side-effects of fluoxetine are likely to outweigh any potential clinical benefit. The most common side-effects experienced by children on antidepressants are weight gain, sleep disturbance and concentration problems."

Twelve large trials published between 1997 and 2024, when pooled, show fluoxetine produced depressive symptom improvements so small they are not clinically meaningful in children and adolescents. Early trials exhibited novelty bias and more positive results, while later trials failed to confirm those effects. Common harms among children taking antidepressants include weight gain, sleep disturbance and concentration problems. The small magnitude of benefit is unlikely to be noticeable to patients or clinicians. Current NICE guidance permits antidepressants for under-18s with moderate to severe depression alongside therapy, but experts recommend removing Prozac from pediatric guidelines given the balance of harms and negligible benefit.

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