The Open-Label Treatment of Attention-Deficit/Hyperactivity Disorder in 4- and 5-Year-Old Children with Beaded Methylphenidate

Abstract

Objective: The aim of this study was to assess the effectiveness and tolerability of a long-acting methylphenidate (MPH) formulation, beaded MPH (B-MPH), for treatment of attention-deficit=hyperactivity disorder (ADHD) in 4-and 5-year-old children. Global Impressions-Severity (CGI-S) scale showed a statistically significant improvement from a baseline mean of 5 to the final visit mean of 3.36 ( p < 0.01). At the final visit, the mean daily B-MPH dose was 17.73 mg. Subjects did not experience any statistically significant changes in weight, blood pressure, or pulse during the study. The most common adverse event was decreased appetite. Conclusion: B-MPH was safe and effective for the treatment of ADHD in the 4-and 5-year-olds participating in this study.

Changes in behavior as side effects in methylphenidate treatment: review of the literature

“…Studies included in the analysis differed in terms of study design, and included randomized parallel-group studies with a placebo arm (13), 21 – 26 , 31 – 44 randomized crossover studies (ten), 14 , 15 , 29 , 36 , 45 – 50 open-label studies (17), 17 , 19 , 27 , 28 , 30 , 32 , 51 – 61 and retrospective studies (four). 16 , 18 , 62 , 63 …”

“…Thirteen of the studies required participants to be methylphenidate-naïve. 15 – 17 , 19 , 23 , 40 – 42 , 44 , 45 , 47 , 53 , 59 , 60 , 64 In 19 of the studies, methylphenidate was discontinued between 1 and 30 days prior to the start of the study. 14 , 22 , 24 , 25 , 28 – 33 , 44 , 48 – 51 , 61 , 65 , 66 Seven of the studies did not specify whether participants had had previous exposure to methylphenidate.…”

“… 18 , 21 , 24 , 25 , 27 – 29 , 31 – 33 , 44 , 49 , 51 , 54 , 56 , 58 , 61 , 65 , 66 Ten were funded using government or university funding. 19 , 23 , 34 – 39 , 43 , 45 , 47 , 48 , 50 , 52 , 64 Four of the studies declared only conflict of interest, 15 , 17 , 26 , 40 – 42 , 64 Five were not in receipt of funding, 16 , 22 , 53 , 57 , 62 while six failed to provide information on funding arrangements. 14 , 30 , 46 , 59 , 60 , 63 …”

“…The study did not receive any funding, and in contrast to the other studies reviewed, did not include participants with concomitant psychiatric disorders. The smallest study selected was Maayan et al, 17 which involved nine very young participants, all of whom were aged between 4 and 5 years and methylphenidate-naïve.…”

“…The review by Aagaard and Hansen was published in 2011. From this paper, we included 14 studies in our review: Biederman et al, 21 Arabgol et al, 22 Maayan et al, 17 Amiri et al, 23 Findling et al, 24 Newcorn et al, 25 Greenhill et al, 26 Gau et al, 27 Silva et al, 14 Kemner et al, 28 Swanson et al, 29 and Kratochvil et al 30 We identified and included an additional 29 studies: eleven of these included adult participants only, or participants between 4 and 65 years of age. Another ten, which involved children and adolescents, were published between 2011 and 2015.…”