Prozac Ineffective for Children with Depression, Experts Warn

Clinical guidelines should no longer recommend Prozac for children, according to experts, after research showed it had no clinical benefit for treating depression in children and adolescents. The World Health Organization reports that globally, one in seven 10 to 19-year-olds have a mental health condition.

In the UK, about a quarter of older teenagers and up to a fifth of younger children suffer from anxiety, depression, or other mental health problems. The National Institute for Health and Care Excellence, or NICE, guidelines currently state that under-18s with moderate to severe depression can be prescribed antidepressants alongside therapy.

However, a new review of trial data by academics in Austria and the UK concluded that fluoxetine, which is sold under the brand name Prozac, is clinically no better than placebo drugs in treating depression in children.

The study, published in the Journal of Clinical Epidemiology, analyzed data from 12 large trials involving Prozac published between 1997 and 2024 and found that fluoxetine improved children's depressive symptoms so minimally that it is not considered clinically meaningful.

Lead author Martin Ploderl, a clinical psychologist at Paracelsus Medical University in Austria, used an analogy to illustrate this point, likening it to a weight-loss drug that achieves a weight loss of only 100 grams more than placebo, an amount unlikely to be noticed by patients or their physicians.

The study highlights a novelty bias in early trials, which tended to report more positive effects, while later studies failed to confirm these benefits. The findings suggest that the potential risks of harmful side effects from fluoxetine, which can include weight gain, sleep disturbances, and increased suicidal ideation, may outweigh any potential clinical benefits.

Co-author Mark Horowitz from Adelaide University emphasized that fluoxetine demonstrates no advantage over placebo and poses greater risks, making it difficult to justify exposing young patients to a drug with known harms.

The research also indicates that clinical guidelines in the US and Canada similarly overlook evidence that Prozac is equivalent to placebo, continuing to recommend its use for depressed children and adolescents.

NICE responded to these findings by reaffirming their commitment to mental health and stating that various treatment options are necessary for clinicians. They recommend psychological therapies as first-line treatments for children and young adults with depression.

However, the need for regular specialist supervision if antidepressants are considered remains. Prof. Allan Young of the Royal College of Psychiatrists cautioned that the study should be interpreted with care, as clinical guidelines take into account many factors beyond average effect size, including safety and patient preferences.

This research raises significant concerns about current clinical guidelines and emphasizes the need for safer treatment alternatives for young patients struggling with depression.