Experts say Prozac is ‘no better than placebo’ for treating depressed children | depression
According to experts, clinical guidelines should no longer recommend Prozac for children Research has shown It has no clinical benefit for treating depression in children and adolescents.
Globally One in seven children between the ages of 10 and 19 have a mental health conditionaccording to the World Health Organization. In the UK, around a quarter of older teenagers and up to a fifth of younger children suffer from anxiety, depression or other mental health problems.
In the UK, National Institute for Health and Care Excellence (NICE) guidelines suggest that people under the age of 18 have moderate to severe depression. Antidepressants may be prescribed alongside treatment.
But a new review of trial data by academics in Austria and the UK has concluded that fluoxetine, sold under the brand name Prozac and others, is no clinically better than placebos at 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 depressive symptoms in children too slightly to be considered clinically meaningful.
“Think of the analogy of a weight-loss drug being better than a placebo at losing weight, but the difference is only 100 grams,” said Martin Bloederle, a clinical psychologist at Paracelsus Medical University in Salzburg, Austria, and lead author of the study. “This difference is unlikely to be noticeable to the patient or their doctors or make any difference to their overall condition.”
The study published in Journal of Clinical EpidemiologyIt identified a “novelty bias” in early trials, which were more likely to be positive, while later studies failed to confirm these effects. It is concluded that the potential risks of adverse side effects of fluoxetine are likely to outweigh any potential clinical benefit.
The most common side effects that children experience when taking antidepressants are weight gain, disturbed sleep, and problems concentrating. They can also increase suicidal ideation.
The researchers also examined clinical guidelines in the United States and Canada and found that, as in the United Kingdom, they ignored evidence suggesting that Prozac was clinically equivalent to placebo and continued to recommend its use to 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 clinically equivalent to placebo in its benefits, but is associated with greater side effects and risks. It is difficult to see how anyone could 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 equivalent to a placebo. Many doctors take the common-sense approach that we should seek to understand the reasons why young people feel depressed and address the factors that contribute to it.”
“Guidelines in the UK and around the world currently recommend treatments for children with depression that are not in line with the best evidence. This exposes young people to the risks of medication with no benefit compared to placebo.”
He added that the long-term effects of antidepressants in children and adolescents are “not well understood,” and research among adults has shown that risks include serious side effects that may be long-term, and in some cases persist after stopping the medication.
In response to the findings, a NICE spokesperson said: “Mental health is a priority for NICE and we recognize that depression in young people is a serious condition that affects each of them differently, which is why having a range of treatment options is essential for clinicians. Our guidance recommends choosing psychological therapies as first-line treatment options for children and young people with depression.
“NICE recommends that children and young people with moderate or severe depression be seen by specialist teams. Antidepressants may be considered in combination with psychotherapy for moderate to severe depression in some cases and under regular specialist supervision only.”
Professor Alan Young, chair of the academic body of the Royal College of Psychiatrists, said the study should be interpreted “with caution”. “Clinical guidelines weigh many factors beyond the average effect size, including safety, feasibility and patient preferences. It is important that a prescribed drug shows consistent evidence and safety data,” he said.