Prozac ‘no better than placebo’ for treating children with depression, experts say | Depression

Clinical guidelines should no longer recommend Prozac for children, experts say, after research showed it had no clinical benefit in treating depression in children and adolescents.

Worldwide, one in seven young people aged 10 to 19 suffer from a mental health problem, according to the World Health Organization. In the UK, around a quarter of older adolescents and up to a fifth of younger children suffer from anxiety, depression or other mental health problems.

In the UK, guidelines from the National Institute for Health and Care Excellence (Nice) indicate that under-18s with moderate to severe depression may be prescribed antidepressants alongside treatment.

But a new analysis of trial data by Austrian and British academics concluded that fluoxetine, sold among others under the brand name Prozac, is clinically no better than placebo drugs for 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 that it was not considered clinically significant.

“Let’s take the analogy of a weight loss drug that is better than a placebo at producing weight loss, but the difference is only 100 grams,” said Martin Plöderl, a clinical psychologist at Paracelsus Medical University in Salzburg, Austria, and lead author of the study. “It is unlikely that this difference will be noticeable to the patient or their doctor or that it will cause a difference in their general condition.”

The study, published in the Journal of Clinical Epidemiology, identified “novelty bias” in early trials, which were likely to be more 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 benefit.

The most common side effects experienced by children taking antidepressants are weight gain, trouble sleeping, and trouble concentrating. They can also increase suicidal thoughts.

The authors also reviewed clinical guidelines in the United States and Canada and found that, just as in the United Kingdom, they ignored the evidence that Prozac was clinically equivalent to placebo and continued to recommend its use in 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 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 placebo-equivalent treatments. Many clinicians take a common-sense approach that we should seek to understand why the young person is feeling 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 consistent with the best evidence. This exposes young people to the risks of medication without any benefit compared to placebo.”

The long-term effects of antidepressants in children and adolescents were “poorly understood” and research in adults showed the risks included serious side effects that can last long-term and, in some cases, persist after treatment is stopped, he added.

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 illness that affects everyone differently, which is why it is essential for clinicians to have a range of treatment options. Our guideline recommends a choice of 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 should be examined by specialist teams. Antidepressants may be considered in combination with psychological therapy for moderate to severe depression in some cases and only under regular specialist supervision.”

Professor Allan Young, chair of the Royal College of Psychiatrists’ academic faculty, said the study should be interpreted with “caution”. “Clinical guidelines consider many factors beyond average effect size, including safety, feasibility and patient preferences. It is important that prescribed medications demonstrate consistent evidence and safety data,” he said.