Washington DC: According to a recent study, most available antidepressants do not help children and teenagers with serious mental health problems and some may be unsafe.
The findings indicate that out of 14 antidepressant drugs, only fluoxetine was more effective at relieving the symptoms of depression than placebo, whilst taking venlafaxine was linked with an increased risk of engaging in suicidal thoughts and attempts compared with placebo and five other antidepressants.
However, the true effectiveness and risk of serious harms such as suicidal thoughts and attempts remains unclear because of the small number and poor design of clinical trials assessing these antidepressants, and the selective reporting of findings in published trials and clinical study reports, caution the authors.
"The balance of risks and benefits of antidepressants for the treatment of major depression does not seem to offer a clear advantage in children and teenagers, with probably only the exception of fluoxetine. We recommend that children and adolescents taking antidepressants should be monitored closely, regardless of the antidepressant chosen, particularly at the beginning of treatment," explains co-author Peng Xie from the Chongqing Medical University.
Lead author Dr Andrea Cipriani at the University of Oxford said, "Without access to individual-level data it is difficult to get accurate effect estimates and we can't be completely confident about the accuracy of the information contained in published and unpublished trials. It has been widely argued that there needs to be a transformation of existing scientific culture to one where responsible data sharing should be the norm."
Cipriani noted that hundreds of thousands of people worldwide have agreed to participate in trials aiming to find better treatments for their disorders and ultimately, help the progress of medical science. Patients' privacy must be guaranteed by adequate policies and technological measures, but delay in implementing responsible data sharing policies has negative consequences for medical research and patient outcomes, as demonstrated by this study. Access to raw clinical trial data provides the unique opportunity not only for validation and replication of results but also the in-depth study of specific factors that may affect treatment outcome at the individual patient level.
Analysis of 34 trials involving 5260 participants (average age 9 to 18 years) showed that the benefits outweighed the risks in terms of efficacy and tolerability only for fluoxetine. Nortriptyline was less efficacious than seven other antidepressants and placebo. Imipramine, venlafaxine, and duloxetine had the worst profile of tolerability, leading to significantly more discontinuations than placebo.
Venlafaxine was linked with an increased risk of engaging in suicidal thoughts or attempts compared with placebo and five other antidepressants. The authors warn that due to the lack of reliable data, it was not possible to comprehensively assess the risk of suicidality for all drugs.
The study is published in The Lancet.