Journal of the American Academy of Child and Adolescent Psychiatry · 2025
Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity Disorder.
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Farhat Luis C, Sugaya Luisa Shiguemi, Bloch Michael H, Childress Ann, Cortese Samuele, Fatori Daniel, Salum Giovanni A, Rohde Luis Augusto, Polanczyk Guilherme V
Аннотация
OBJECTIVE: This study aimed to identify moderators of efficacy of stimulants against placebo to inform personalized recommendations for treatment in preschool children (<6 years of age) with attention-deficit/hyperactivity disorder (ADHD).
METHOD: We acquired individual-level participant data from 2 randomized placebo-controlled trials (RCTs) of preschool ADHD: namely, MAPPA (8-week methylphenidate, 102 participants, Brazil) and SPD489-347 (6-week lisdexamfetamine, 148 participants, United States). We evaluated the moderator and predictor effects of baseline demographic (age, sex, race, ethnicity, maternal educational level) and baseline clinical (ADHD symptom severity, intelligence quotient, number of psychiatric comorbidities) characteristics, as available, on endpoint ADHD symptom severity scores. Data from each study were analyzed separately with linear mixed-effects model for repeated measures. For categorical variables, we also computed treatment effects (ie, stimulants vs placebo) within subgroups and, when possible, pooled them alongside subgroup data from the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS) (5-week methylphenidate, 165 participants, United States) in random-effects meta-analyses.
RESULTS: Stimulants had greater efficacy against placebo in White children compared to Black children when considering data from US studies. Older age was not a moderator of greater efficacy of stimulants against placebo, nor was it associated with worse ADHD symptom severity at endpoint. Greater baseline ADHD symptom severity was associated with higher ADHD symptom severity at endpoint independently of the assigned treatment group.
CONCLUSION: Race, but not older age or baseline ADHD symptom severity, may moderate the efficacy of stimulants for preschool ADHD. Given the post hoc nature of subgroup analyses, the findings should be interpreted as exploratory and viewed as hypotheses for confirmation in future studies.
PLAIN LANGUAGE SUMMARY: In this individual participant meta-analysis, the authors obtained data from 2 clinical trials of psychostimulants for preschool children (aged 6 years or younger) with attention-deficit/hyperactivity disorder (ADHD) to investigate associations between demographic, clinical characteristics, and treatment effects. One study was focused on methylphenidate and was conducted in Brazil with 102 participants. The other study focused on lisdexamfetamine and was conducted in the United States with 148 participants. Some analyses also included subgroup data from a study focused on methylphenidate and was conducted in the US with 165 participants. In the US studies, stimulants appeared to work better in White children than in Black children, while older age or clinical severity was not associated with effectiveness of stimulants. The authors emphasize that these findings are exploratory and should be confirmed in future studies before guiding clinical decisions.
CLINICAL TRIAL REGISTRATION INFORMATION: Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD); https://clinicaltrials.gov/study/NCT03260205; Early Interventions in Children With Attention Deficit/Hyperactivity Disorder; https://clinicaltrials.gov/study/NCT02807870.
METHOD: We acquired individual-level participant data from 2 randomized placebo-controlled trials (RCTs) of preschool ADHD: namely, MAPPA (8-week methylphenidate, 102 participants, Brazil) and SPD489-347 (6-week lisdexamfetamine, 148 participants, United States). We evaluated the moderator and predictor effects of baseline demographic (age, sex, race, ethnicity, maternal educational level) and baseline clinical (ADHD symptom severity, intelligence quotient, number of psychiatric comorbidities) characteristics, as available, on endpoint ADHD symptom severity scores. Data from each study were analyzed separately with linear mixed-effects model for repeated measures. For categorical variables, we also computed treatment effects (ie, stimulants vs placebo) within subgroups and, when possible, pooled them alongside subgroup data from the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS) (5-week methylphenidate, 165 participants, United States) in random-effects meta-analyses.
RESULTS: Stimulants had greater efficacy against placebo in White children compared to Black children when considering data from US studies. Older age was not a moderator of greater efficacy of stimulants against placebo, nor was it associated with worse ADHD symptom severity at endpoint. Greater baseline ADHD symptom severity was associated with higher ADHD symptom severity at endpoint independently of the assigned treatment group.
CONCLUSION: Race, but not older age or baseline ADHD symptom severity, may moderate the efficacy of stimulants for preschool ADHD. Given the post hoc nature of subgroup analyses, the findings should be interpreted as exploratory and viewed as hypotheses for confirmation in future studies.
PLAIN LANGUAGE SUMMARY: In this individual participant meta-analysis, the authors obtained data from 2 clinical trials of psychostimulants for preschool children (aged 6 years or younger) with attention-deficit/hyperactivity disorder (ADHD) to investigate associations between demographic, clinical characteristics, and treatment effects. One study was focused on methylphenidate and was conducted in Brazil with 102 participants. The other study focused on lisdexamfetamine and was conducted in the United States with 148 participants. Some analyses also included subgroup data from a study focused on methylphenidate and was conducted in the US with 165 participants. In the US studies, stimulants appeared to work better in White children than in Black children, while older age or clinical severity was not associated with effectiveness of stimulants. The authors emphasize that these findings are exploratory and should be confirmed in future studies before guiding clinical decisions.
CLINICAL TRIAL REGISTRATION INFORMATION: Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD); https://clinicaltrials.gov/study/NCT03260205; Early Interventions in Children With Attention Deficit/Hyperactivity Disorder; https://clinicaltrials.gov/study/NCT02807870.