Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day
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BACKGROUND: Efficacy and safety profiles by sex and age (6-9 vs 10-12 years) and magnitude and duration of effect by effect size overall and across the day of lisdexamfetamine dimesylate (LDX) vs placebo were assessed. METHODS: This study enrolled children (6-12 years) with attention-deficit/hyperactivity disorder (ADHD) in an open-label dose optimization with LDX (30-70 mg/d) followed by a randomized, double-blind, placebo-controlled, 2-way crossover phase. Post hoc analyses assessed interaction between sex or age and treatment and assessed effect sizes for Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and Permanent Product Measure of Performance (PERMP) scales and ADHD Rating Scale IV measures. No corrections for multiple testing were applied on time points and subgroup statistical comparisons. RESULTS: 129 participants enrolled; 117 randomized. Both sexes showed improvement on all assessments at postdose time points; females showed less impairment than males for SKAMP and PERMP scores in treatment and placebo groups at nearly all times. Both age groups improved on all assessments at postdose time points. Children 10-12 years had less impairment in SKAMP ratings than those 6-9 years. Treatment-by-sex interactions were observed at time points for SKAMP-D, SKAMP total, and PERMP scores; no consistent pattern across scales or time points was observed. LDX demonstrated significant improvement vs placebo, by effect size, on SKAMP-D from 1.5-13 hours postdose. The overall LS mean (SE) SKAMP-D effect size was -1.73 (0.18). In the dose-optimization phase, common (≥2%) treatment-emergent adverse events (TEAEs) in males were upper abdominal pain, headache, affect lability, initial insomnia, and insomnia; in females were nausea and decreased weight. During the crossover phase for those taking LDX, higher incidence (≥2% greater) was observed in males for upper abdominal pain and insomnia and in females for nausea and headache. Overall incidence of TEAEs in age groups was similar. CONCLUSION: Apparent differences in impairment level between sex and age groups were noted. However, these results support the efficacy of LDX from 1.5 hours to 13 hours postdose in boys and girls with medium to large effect sizes across the day with some variability in TEAE incidence by sex. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT00500149.
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Age and sex influence the effectiveness of medication treatment.
“At the same time, the factors of age and sex also complicate individual medication selection as they influence the effectiveness of medication treatment (Childress, Newcorn, & Cutler, 2019; Dafny & Yang, 2006; Wigal, Kollins, Childress, & Adeyi, 2010).”
From Overlapping and differential neuropharmacological mechanisms of stimulants and nonstimulants for attention-deficit/hyperactivity disorder: A comparative neuroimaging analysis (2024) · cites this paper as Wigal, Kollins, Childress, & Adeyi, 2010
The Background describes mixed evidence on whether age and sex moderate ADHD medication response, including a study reporting sex differences in response to methylphenidate. But this paper’s Discussion (Effects of age; Effects of Sex, pages unavailable) says both age groups responded to lisdexamfetamine and found no consistent treatment-by-sex interactions. It therefore does not establish the broad claim that both factors influence medication effectiveness or complicate individual medication selection. (LLM, conf=0.86)
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- Authors
- Wigal, S. B., Kollins, S. H., Childress, A. C., & Adeyi, B.
- Affiliations
- University of California, Irvine (US)
- Duke Medical Center (US)
- Center for Psychiatry and Behavioral Medicine (US)
- Corresponding author
- Wigal, Sharon B
- Venue
- Child and Adolescent Psychiatry and Mental Health
- Published
- 2010-12
- Volume
- 4
- Issue
- 1
- Pages
- 32-32
- ISSN
- 1753-2000 (ISSN-L)
- PMC
- PMC3022598
- OpenAlex
- W2146800281
- Cited by
- 23
- References
- 48
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2020: 1 · 2019: 3 · 2016: 3 · 2015: 3 · 2013: 3 · 2012: 4
- FWCI
- 1.75
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Child and Adolescent Psychiatry and Mental Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, children, sex differences, age differences, treatment-emergent adverse events, dose optimization, ADHD Rating Scale-IV, crossover trial, epigastric pain, nausea, headache
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