Gender Effects in the Efficacy of Racemic Amphetamine Sulfate in Children with Attention-Deficit/Hyperactivity Disorder
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INTRODUCTION: A laboratory classroom study in children aged 6-12 years with attention-deficit/hyperactivity disorder (ADHD) found that racemic amphetamine sulfate (RA-AMPH) significantly improved performance versus placebo from 45 min through 10 h post-dose (NCT01986062). A secondary analysis assessed gender as a potential moderator of response to treatment comparing the ADHD Rating Scale-IV (ADHD-RS-IV) and Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scales. METHODS: After 8 weeks of open-label RA-AMPH dose optimization using improvement in ADHD-RS-IV symptoms as a guide, 97 subjects (38 females and 59 males) were randomized to the sequence of 2 weeks of double-blind treatment with the optimized dose of RA-AMPH followed by placebo or vice versa during a laboratory classroom day. Efficacy measures included the SKAMP and the Permanent Product Measure of Performance (PERMP). The average difference for RA-AMPH versus placebo was estimated using least-square (LS) means. Treatment interaction by gender was analyzed using a cross-sectional fixed-effects model. RESULTS: ADHD-RS-IV scores were comparable for males and females at study entry and at the end of open-label treatment. During double-blind treatment, LS mean scores significantly improved for both genders versus placebo on the SKAMP scale and the PERMP (average p < 0.0001 for all post-dose time points). Beginning at baseline, males had significantly higher (worse) SKAMP scores than females but not worse ADHD-RS-IV or PERMP scores. CONCLUSION: Both genders responded well to treatment with RA-AMPH, with comparable onset and duration of effect. The ADHD-RS-IV and SKAMP scales both measure changes in attention and hyperactive-impulsive behavior, but the SKAMP scale also measures associated disruptive behaviors, such as frustration, lying, and interpersonal conflict, that are more characteristic of oppositional and conduct disorders and more prevalent in boys with ADHD. Therefore, the SKAMP may be more sensitive for measuring the range of symptoms of boys with ADHD than the ADHD-RS-IV. FUNDING: Arbor Pharmaceuticals, LLC.
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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 Childress, Newcorn, & Cutler, 2019
The Conclusion (page not provided) says boys and girls with ADHD responded equally well to racemic amphetamine sulfate, with comparable onset and duration of effect. The Results found no significant or consistent difference in effect size by gender, apart from isolated treatment-by-gender interactions at 2 hours. The paper does not establish that age influences treatment effectiveness. (LLM, conf=0.88)
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“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).”
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- Authors
- Childress, A. C., Newcorn, J. H., & Cutler, A. J.
- Affiliations
- Center for Psychiatry and Behavioral Medicine (US)
- Meridien Research (US)
- Corresponding author
- Childress, Ann C.
- Venue
- Advances in Therapy
- Published
- 2019-04-10
- Volume
- 36
- Issue
- 6
- Pages
- 1370-1387
- ISSN
- 0741-238X (ISSN-L)
- 1865-8652
- PMC
- PMC6824382
- OpenAlex
- W2937281867
- Cited by
- 6
- References
- 34
- Citations by year
- 2025: 1 · 2024: 4 · 2021: 1
- FWCI
- 0.20
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Advances in Therapy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- Arbor Pharmaceuticals, LLC.
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- attention deficit hyperactivity disorder, gender differences, treatment response, ADHD Rating Scale-IV, stimulant medication, disruptive behavior
- MeSH terms
- Amphetamine, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Cross-Sectional Studies, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Psychiatric Status Rating Scales, Sex Factors, United States, Treatment Outcome
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