ADHD in Very Young Children: Treatment Challenges
Kratochvil CJ, Vaughan BS, Stoner JA, et al
Pediatrics. 2011;127:e862-e868. Epub 2011 Mar 21
Clinicians often have to treat young children with medication for attention-deficit/hyperactivity disorder (ADHD), but there is a relative dearth of data on the efficacy of ADHD medications in this younger cohort, particularly the preschool age group. This 8-week trial was conducted at 3 sites in the United States during 2005-2008. The children were all diagnosed with ADHD using a standardized instrument, and were in preschool or school at least 2 half days each week. Children with low performance on cognitive testing, unstable home environments, and other clinical and social features that would potentially influence outcomes were excluded. Children received either active treatment with atomoxetine or placebo in a 1:1 ratio, with atomoxetine begun at 0.5 mg/kg/day and titrated to 1.8 mg/kg/day as needed.
During the study period, children made 4 weekly visits followed by biweekly visits to the investigative sites. During those sessions, all parents received education about ADHD and management strategies. The primary outcome of interest was the children's scores on the ADHD Rating Scale-IV. All rating scale data were collected by an investigator who interviewed each parent. In addition, teachers completed an educator version of the rating scale before randomization and again at 3 and 8 weeks.
The sample included 49 children randomly assigned to placebo and 44 assigned to active drug. The mean age of the children was 6.1 years. The sample was approximately 30% girls. Although the majority of the children were white, 19% were Hispanic, 10% black, and 6% Native American. All but 13 of the children were in either kindergarten or first grade; the others were in preschool (11) or second grade (2). More than 80% had combined-type ADHD, and approximately one third had comorbid oppositional defiant disorder. The study was not completed by 18 of the 93 children.
Children in the treatment group experienced a significantly greater decline in ADHD Rating Scale scores compared with children in the placebo group, a score reduction that was twice as great in children who received the active drug. The relative benefit was seen in treatment group children even when stratified by ADHD subtype. The treatment children demonstrated greater improvement on parent-completed and teacher-completed ADHD Rating Scale-IV scores. Treatment group children experienced a slight reduction in body weight, whereas placebo group children experienced a slight weight gain. Both treatment and placebo groups experienced an initial improvement in rating scale scores, but the trajectories diverged at approximately 4 weeks into the study. The treatment group's scores continued to decline, and then reached a plateau. After the initial decline, the placebo group scores rebounded, but not back to baseline. The investigators noted that, despite the differences between the groups, only 40% of the children attained poststudy scores in the acceptable range, with most retaining clinically significant scores.
Two findings of this study struck me as interesting. First, the fact that 4 weeks elapsed on treatment before the scores of the treatment group diverged from those of the placebo group is worth emphasizing to parents and remembering as clinicians. Reiterating to parents that they should not expect quick changes in symptoms is very important to achieving therapeutic goals and improving drug adherence. Second, atomoxetine may not produce a desired response in most 5- and 6-year-old children. With only the data from this study, it is difficult to know how much of the disappointing response is a consequence of the drug or of the challenges of treating ADHD in very young children. It would be helpful to see a similar study with more children, including a group who received traditional stimulant medication, to help clinicians decide where atomoxetine might fit into the medication repertoire for early elementary school-age children with ADHD.
Abstract
A Double-Blind, Placebo-Controlled Study of Atomoxetine in Young Children With ADHD
Kratochvil CJ, Vaughan BS, Stoner JA, et al
Pediatrics. 2011;127:e862-e868. Epub 2011 Mar 21
Study Summary
Clinicians often have to treat young children with medication for attention-deficit/hyperactivity disorder (ADHD), but there is a relative dearth of data on the efficacy of ADHD medications in this younger cohort, particularly the preschool age group. This 8-week trial was conducted at 3 sites in the United States during 2005-2008. The children were all diagnosed with ADHD using a standardized instrument, and were in preschool or school at least 2 half days each week. Children with low performance on cognitive testing, unstable home environments, and other clinical and social features that would potentially influence outcomes were excluded. Children received either active treatment with atomoxetine or placebo in a 1:1 ratio, with atomoxetine begun at 0.5 mg/kg/day and titrated to 1.8 mg/kg/day as needed.
During the study period, children made 4 weekly visits followed by biweekly visits to the investigative sites. During those sessions, all parents received education about ADHD and management strategies. The primary outcome of interest was the children's scores on the ADHD Rating Scale-IV. All rating scale data were collected by an investigator who interviewed each parent. In addition, teachers completed an educator version of the rating scale before randomization and again at 3 and 8 weeks.
The sample included 49 children randomly assigned to placebo and 44 assigned to active drug. The mean age of the children was 6.1 years. The sample was approximately 30% girls. Although the majority of the children were white, 19% were Hispanic, 10% black, and 6% Native American. All but 13 of the children were in either kindergarten or first grade; the others were in preschool (11) or second grade (2). More than 80% had combined-type ADHD, and approximately one third had comorbid oppositional defiant disorder. The study was not completed by 18 of the 93 children.
Children in the treatment group experienced a significantly greater decline in ADHD Rating Scale scores compared with children in the placebo group, a score reduction that was twice as great in children who received the active drug. The relative benefit was seen in treatment group children even when stratified by ADHD subtype. The treatment children demonstrated greater improvement on parent-completed and teacher-completed ADHD Rating Scale-IV scores. Treatment group children experienced a slight reduction in body weight, whereas placebo group children experienced a slight weight gain. Both treatment and placebo groups experienced an initial improvement in rating scale scores, but the trajectories diverged at approximately 4 weeks into the study. The treatment group's scores continued to decline, and then reached a plateau. After the initial decline, the placebo group scores rebounded, but not back to baseline. The investigators noted that, despite the differences between the groups, only 40% of the children attained poststudy scores in the acceptable range, with most retaining clinically significant scores.
Viewpoint
Two findings of this study struck me as interesting. First, the fact that 4 weeks elapsed on treatment before the scores of the treatment group diverged from those of the placebo group is worth emphasizing to parents and remembering as clinicians. Reiterating to parents that they should not expect quick changes in symptoms is very important to achieving therapeutic goals and improving drug adherence. Second, atomoxetine may not produce a desired response in most 5- and 6-year-old children. With only the data from this study, it is difficult to know how much of the disappointing response is a consequence of the drug or of the challenges of treating ADHD in very young children. It would be helpful to see a similar study with more children, including a group who received traditional stimulant medication, to help clinicians decide where atomoxetine might fit into the medication repertoire for early elementary school-age children with ADHD.
Abstract