Prozac ‘no better than placebo’ for treating children with depression, experts say | Depression
Clinical guidelines should no longer recommend Prozac for children after studies showed it provided no clinical benefit in treating depression in children and adolescents, experts say.
globally One in seven people aged 10-19 has a mental health problemAccording to the World Health Organization. A quarter of teenagers and a fifth of young children in the UK have anxiety, depression or other mental health problems.
In the UK, National Institute for Health and Care Excellence (Nice) guidance says people under 18 are more likely to have moderate to severe depression In addition to treatment, antidepressants may also be prescribed.
But a new review of trial data by academics in Austria and the UK has concluded that fluoxetine, sold under the brand name 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 studies involving Prozac, published between 1997 and 2024, and concluded that fluoxetine improved depressive symptoms in children too little to be considered clinically significant.
“Consider the analogy of a weight-loss drug being better than a placebo at losing weight, but the difference is only 100 grams,” said Martin Plöderl, a clinical psychologist at the Paracelsus Medical University in Salzburg, Austria, and the study’s lead author. “This difference is unlikely to be noticed by the patient or doctor or to make any difference to their overall condition.”
Published in the study Journal of Clinical EpidemiologyWhile early trials identified a “recency bias” that was likely more positive, 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 in children using antidepressants are weight gain, sleep disturbance and concentration problems. They may also increase suicidal ideation.
The authors also examined clinical guidelines in the US and Canada and found that, just like in 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 clinically equivalent to placebo in terms of its benefits, but is associated with greater side effects and risks. It is difficult to see how exposing young people to a drug with known harms that has no advantage over placebo in terms of benefits can be justified.”
“Guidelines should not recommend placebo-equivalent treatments. Many clinicians take the common-sense approach that we need to understand why the young person feels depressed and address contributing factors.”
“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 without providing any benefit compared to placebo.”
He added that the long-term effects of antidepressants in children and adolescents are “poorly understood” and that studies among adults have shown that the risks include serious side effects that can be long-term and, in some cases, continue after stopping the drug.
Responding 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 person differently, so having a range of treatment options is crucial 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 examined by specialist teams. Antidepressants may be considered in some cases in conjunction with psychological therapy for moderate to severe depression and only under regular specialist supervision.”
Prof Allan Young, Head of the Academic Faculty of the Royal College of Psychiatrists, said the study should be interpreted “with caution”. “Clinical guidelines weigh many factors beyond average effect size, including safety, feasibility, and patient preferences. It is important that prescription drugs demonstrate consistent evidence and safety data,” he said.
