Experts are calling for a review of clinical guidelines after research showed that Prozac does not effectively treat depression in children and adolescents.
Globally, about one in seven young people aged 10–19 has a mental health condition, according to the World Health Organization. In the UK, roughly a quarter of older teenagers and up to one-fifth of younger children experience anxiety, depression, or other mental health issues.
Current UK guidelines from the National Institute for Health and Care Excellence (NICE) allow prescribing antidepressants like Prozac alongside therapy for under-18s with moderate to severe depression.
However, a new study by researchers in Austria and the UK analyzed 12 large trials of Prozac (fluoxetine) conducted between 1997 and 2024. They concluded that the drug’s effect on children’s depressive symptoms is so small that it is not clinically meaningful.
Martin Plöderl, a clinical psychologist at Paracelsus Medical University and lead author, explained: “Imagine a weight-loss drug that helps you lose just 100 grams more than a placebo. The difference is barely noticeable. That is similar to Prozac’s effect in children.”
Published in the Journal of Clinical Epidemiology, the study also found that early trials showed overly positive results due to a “novelty bias,” while later studies failed to replicate these benefits. The potential harms of fluoxetine, the researchers warn, likely outweigh any small benefits.
Common side effects of antidepressants in children include weight gain, sleep problems, and concentration difficulties. In some cases, these medications may increase suicidal thoughts.
The researchers also reviewed guidelines in the US and Canada. Like the UK, they often continue to recommend Prozac for children despite evidence showing it works no better than placebo.
Mark Horowitz, associate professor of psychiatry at Adelaide University and co-author of the study, said: “Fluoxetine offers no clinical advantage over placebo, but it carries real risks. Exposing young people to a drug that does not help is hard to justify.”
He added that guidelines should focus on understanding why a child feels depressed and addressing those factors directly, rather than relying on medications with limited evidence of benefit.
The long-term effects of antidepressants in children and adolescents remain poorly understood. Studies in adults suggest that some side effects can be serious and persist even after stopping the medication.
In response, a NICE spokesperson emphasized the importance of a range of treatment options. “Psychological therapies are the first-line treatment for children and young people with depression. Antidepressants may be considered in some cases but only under specialist supervision,” they said.
Prof Allan Young, chair of the Royal College of Psychiatrists’ Academic Faculty, urged caution in interpreting the study. “Guidelines consider factors beyond average effect size, including safety, feasibility, and patient preferences. Medications must show consistent evidence and safety,” he said.
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