Randomized, placebo-controlled, crossover study of methylphenidate for attention-deficit/hyperactivity disorder
Jaswinder K Ghuman1, Michael G Aman, Luc Lecavalier
1University of Arizona , Child and Adolescent Psychiatry, Tucson, Arizona 85724-5002, USA. jkghuman@email.arizona.edu
Insights
Methylphenidate (MPH) showed short-term benefits for attention-deficit/hyperactivity disorder (ADHD) in preschoolers with developmental disorders. Close monitoring is advised due to potential side effects in this population.
Area of Science:
- Pediatric Neurology
- Child Psychiatry
- Developmental Psychology
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is common in preschoolers with developmental disorders (DD), including pervasive developmental disorder (PDD) and intellectual disability (ID).
- Limited research exists on methylphenidate (MPH) efficacy and safety in this specific pediatric population.
Purpose of the Study:
- To evaluate the short-term effectiveness of MPH in treating ADHD symptoms in preschoolers with PDD or ID.
- To assess the safety and tolerability of MPH in this understudied group.
Main Methods:
- A single-blind titration followed by a 4-week double-blind crossover study.
- Fourteen preschoolers with DD (PDD, n=12; ID, n=2) received placebo and optimal MPH doses for 2 weeks each.
- The Conners' Parent Rating Scale-Revised (CPRS-R-DSM-IV-ADHD) was the primary outcome measure.
Main Results:
- MPH improved parent-rated ADHD symptoms, with 50% of preschoolers identified as responders.
- Significant improvement was noted in the PDD subgroup (p=0.005, Cohen d=0.97).
- Half of the children experienced side effects, including behavioral and sleep issues; one discontinued treatment.
Conclusions:
- MPH demonstrates a positive, albeit variable, effect on ADHD symptoms in preschoolers with PDD/ID.
- High rates of adverse effects necessitate careful monitoring in this vulnerable population.
- Further research is needed to optimize MPH treatment strategies for preschoolers with co-occurring ADHD and developmental disorders.
Objective:
The aim of this study was to investigate the short-term efficacy and safety of methylphenidate (MPH) to treat attention-deficit/hyperactivity disorder (ADHD) symptoms in an understudied population of preschoolers with pervasive developmental disorder (PDD) or intellectual disability (ID).
Methods:
Fourteen preschoolers with developmental disorders (DD, n = 14; PDD, n = 12; ID, n = 2) underwent MPH titration in a single-blind manner followed by a 4-week double-blind crossover phase. Each child was administered placebo for 2 weeks and "optimal dose" for 2 weeks. The primary outcome measure was the Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition (DSM-IV) ADHD subscale of the Conners' Parent Rating Scale-Revised (CPRS-R-DSM-IV-ADHD).
Results:
MPH improved parent-rated ADHD symptoms of the preschoolers; 50% were rated as responders. The CPRS-R-DSM-IV-ADHD subscale was significant for the PDD subgroup (p = 0.005, Cohen d = 0.97) and marginally significant for the entire DD sample (p = 0.08, Cohen d = 0.50). Half of the preschoolers experienced side effects with MPH, including reports of increased stereotypic behavior, upset stomach, sleep-related difficulties, and emotional lability. One child discontinued during titration due to side effects.
Conclusion:
The predominant direction of response in these preschoolers with both ADHD and PDD/ID favored MPH, even though the response was more subtle and variable than in older and typically developing children. Due to high rates of adverse effects, preschoolers should be monitored closely.
