According to experts, clinical guidelines should no longer recommend Prozac for children, as research has shown that it has no clinical benefit for treating depression in children and adolescents.
According to the World Health Organization, one in seven children aged 10–19 globally has a mental health condition. In Britain, almost a quarter of older teenagers and up to a fifth of younger children have anxiety, depression or other mental health problems.
In the UK, guidance from the National Institute for Health and Care Excellence (Nice) states that people under 18 with moderate to severe depression may be prescribed antidepressants along with therapy.
But a new review of trial data by academics in Austria and the UK concluded that fluoxetine, sold under the brand name Prozac, is no longer clinically superior to placebo drugs in treating depression in children, and so they should no longer be prescribed.
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 that it could not be considered clinically meaningful.
“Consider the analogy of a weight-loss drug that is better than a placebo at weight loss, but the difference is only 100 grams,” said study lead author Martin Ploederl, a clinical psychologist at Paracelsus Medical University in Austria and a professor at Paracelsus Medical University in Austria. “This difference is unlikely to be noticeable to patients or their doctors or to make any difference in their overall condition.”
The study, published in the Journal of Clinical Epidemiology, identified a “novelty bias” in early trials that were more likely to be positive, while later studies failed to confirm these effects. It concludes that the potential risks of harmful side effects of fluoxetine are likely to outweigh any potential clinical benefits.
The most common side effects experienced by children taking antidepressants are weight gain, sleep disturbances, and concentration problems. They can also increase suicidal tendencies.
The authors also examined clinical guidelines in the US and Canada and found that, like the UK, they ignored evidence that Prozac was clinically equivalent to placebo and continued to recommend its use for children and adolescents with depression.
Mark Horowitz, associate professor of psychiatry at the University of Adelaide and co-author of the study, said: “Fluoxetine is clearly therapeutically equivalent to placebo in its benefits, but is associated with more side effects and risks. It is difficult to see how anyone can justify exposing young people to a drug with known harms when it has no advantage over placebo in its benefits.
“Guidelines should not recommend treatments that are equivalent to placebo. Many clinicians take the common sense approach that we should try to understand why the young person feels depressed and look at the factors that are contributing to this.
“Guidelines in the UK and around the world currently recommend treatments for children with depression that are not consistent with the best evidence. This exposes young people to the risks of the drug without any benefit compared to placebo.”
They said the long-term effects of antidepressants in children and adolescents were “poorly understood” and that research among adults showed that the risks included serious side effects that could be long-term and in some cases persist even after stopping the medication.
Responding to the findings, a spokesperson for NICE said: “Mental health is a priority for NICE and we recognize that depression in young people is a serious condition that affects everyone differently, which is why it is essential for practitioners to have a range of treatment options. Our guideline recommends a choice of psychological therapies as a first-line treatment option for children and young people with depression.
“NICE recommends that children and young people with moderate or severe depression be reviewed by specialist teams. A combination of antidepressants with psychological therapy may be considered for moderate to severe depression in some cases and only under regular specialist supervision.”
Professor Alan Young, chair of the academic faculty of the Royal College of Psychiatrists, said the study should be interpreted “with caution”. “Clinical guidelines value many factors beyond average effect size, including safety, feasibility, and patient preferences. It is important that the prescribed drug demonstrate consistent evidence and safety data,” he said.