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Hi! David Rosenberg here for the Psychopharmacology Institute. In this Child and Adolescent Psychiatry Smart Take, we will look at diagnosing and treating preschool children with ADHD, which means preschool children from 4 to less than 6 years of age.
There is increasing recognition that ADHD symptoms exist in preschool children, and in some instances, behavioral and nonmedication interventions are not sufficient. Of course, you always want to start with nonmedication interventions, such as behavioral modifications or looking at the family. We certainly do not want to rush to medicate.
Interestingly, amphetamine compounds, such as Adderall, are FDA approved for ADHD in children 3 years and older. Other methylphenidate stimulants are FDA approved for children 6 years and older. Both are being used when necessary in these younger populations.
Moreover, this study is interesting because it is the first long-term, 1-year trial of any long-acting methylphenidate compound in preschool children aged 4 to less than 6. So, it is an understudied area and critical to look at. Is it really safe? Can this medicine be used long term in very, very young children? This study said yes since it was well-tolerated and the discontinuation rate and side effects were similar to what has been observed in older children. So, we have often heard that methylphenidate reduces height and weight, which has been a big concern over the years. This study, interestingly consistent with prior studies, found a dose-related reduction in expected weight and height, which was minimal and decreased over time. The bottom line is that it does not appear that the statistically significant change in weight or height is clinically significant.
The same holds for changes in blood pressure or heart rate. There can be statistically significant changes in heart rate and blood pressure in children and adolescents treated with stimulants, but this is rarely, if ever, clinically significant. For example, a regular heart rate is typically between 60 bpm to 100 bpm. If a particular child has a pulse of 68 bpm and after being treated with methylphenidate, their pulse is 72, that may be a statistically significant change but is unlikely to be clinically significant. We recommend regular heart rate monitoring for children and adolescents treated with stimulants, particularly with dose increases, but even during routine monitoring, check heart rate and ask about any cardiovascular symptoms.
Another point I will raise is that sleep disruption is often recognized in children with ADHD, but it seems independent from medication. So, I always get a sleep diary and detailed sleep information from the child and parent before starting the stimulant medication. You will often find that there is either no change in the sleep pattern or it even improves as the ADHD and related symptoms are treated. I think it is essential to get a baseline because there has been this long-time association of stimulants with sleep disruption, and although that may be possible, it is the exception rather than the rule.
Overall, I think this was a well-done report, but there are limitations—the most important one being that Rhodes Pharmaceutical funded it, and Rhodes reviewed and gave feedback on the paper to the authors. Rhodes also provided funding for the analyses. So, it is noted that the authors had complete editorial control of the paper and provided final approval of its content, but the sponsor, Rhodes Pharmaceutical, clearly had input into this publication.
The good news is that it does look like methylphenidate compounds—extended release in particular—are safe and effective in preschool children who need medication. However, I want to emphasize that this should not be something that clinicians rush to do—to medicate preschool children younger than 6 years of age. You only want to do this after behavioral and family interventions have been tried and are clearly ineffective. Moreover, you have to measure and weigh the risks–benefits. Are the symptoms so severe and unable to be controlled that it makes using medication reasonable?
Abstract
Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years
Ann C Childress, Henry C Foehl, Jeffrey H Newcorn, Stephen V Faraone, Benjamin Levinson, Akwete L Adjei
Objective: To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years after treatment optimization.
Method: A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses.
Results: Most TEAEs (89.9%) were rated by investigators as of mild or moderate severity. One serious AE was reported (unrelated to study drug). Ten children discontinued because of TEAEs. Two discontinued because of weight loss; no significant increase in the rate of underweight children from baseline to endpoint was observed. Overall, 18% lost weight and 18% reported decreased appetite. Weight and height z scores and obesity rates decreased significantly from baseline to endpoint. Insomnia was reported (9%); none of these children discontinued. Sleep quality did not change significantly. Hypertension was reported (6.7%); none of these children dropped out. Diastolic, but not systolic, blood pressure increased significantly during the follow-up. Control of ADHD symptoms was maintained throughout follow-up.
Conclusion: These data contribute to the understanding of the long-term safety of an extended-release stimulant in children 4 to <6 years of age. The observed risk of a TEAE-related discontinuation was ∼11%. TEAEs were not dose related, and most were of mild to moderate severity. Symptom control was maintained through the year-long study.
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Reference
Childress, A. C., Foehl, H. C., Newcorn, J. H., Faraone, S. V., Levinson, B., & Adjei, A. L. (2022).
Long-term treatment with extended-release methylphenidate treatment in children aged 4 to <6 years.
Journal of the American Academy of Child and Adolescent Psychiatry, 61
(1), 80-92.
