Double-Blind, Placebo-Controlled Study of Single-Dose Amphetamine Formulations in ADHD
Abstract
Objective To compare the efficacy and time course of single morning doses of Adderall, extended-release, and immediate-release dextroamphetamine sulfate.Method Thirty-five children with attention-deficit/hyperactivity disorder, combined type, were given Adderall, immediate-release dextroamphetamine, dextroamphetamine Spansules, and placebo in a randomized, double-blind, crossover study. Behavior ratings, locomotor activity measurements, and academic measures were obtained over a period of 8 weeks.Results All three drugs exhibited robust efficacy versus placebo on nearly all measures. The effects of dextroamphetamine Spansules were less robust in the morning, particularly compared with Adderall, but they lasted 3 to 6 hours longer, depending on the measure. Although parent behavior ratings and locomotor activity showed improvements up to 12 hours after single doses of all three drugs, the number of math problems attempted and completed correctly 4 hours after dosing were only robustly increased by Spansules.Conclusions Both immediate-release amphetamines demonstrated earlier onset of effects, but dextroamphetamine Spansules showed more sustained effects that were present on a wider range of measures.
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James et al. (2001) described locomotor activity effects of amphetamine preparations up to 12 hours postdose but did not repeatedly probe disruptive behavior or academic performance.
“James et al. (2001) recently described locomotor activity effects of amphetamine preparations up to 12 hours postdose, but they did not repeatedly probe disruptive behavior or academic performance.”
From Analog Classroom Assessment of a Once-Daily Mixed Amphetamine Formulation, SLI381 (ADDERALL XR), in Children With ADHD (2003) · cites this paper as James et al., 2001
The locomotor activity reductions observed by James et al. (2001) were of uncertain clinical significance because of lacking repeated assessments of behavior and academic function.
“but lacking repeated assessments of behavior and academic function, the observed locomotor activity reductions were of uncertain clinical significance.”
From Analog Classroom Assessment of a Once-Daily Mixed Amphetamine Formulation, SLI381 (ADDERALL XR), in Children With ADHD (2003) · cites this paper as James et al. (2001)
James et al. (2001) showed statistically significant reductions in locomotor activity for up to 12 hours for some high-dose amphetamine preparations.
“James et al. (2001) showed statistically significant reductions in locomotor activity for up to 12 hours for some high-dose amphetamine preparations”
From Analog Classroom Assessment of a Once-Daily Mixed Amphetamine Formulation, SLI381 (ADDERALL XR), in Children With ADHD (2003) · cites this paper as James et al. (2001)
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- Authors
- JAMES, R. S., SHARP, W. S., BASTAIN, T. M., LEE, P. P., WALTER, J. M., CZARNOLEWSKI, M., & CASTELLANOS, F. X.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- CASTELLANOS, F. XAVIER
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2001-11
- Volume
- 40
- Issue
- 11
- Pages
- 1268-1276
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2024285816
- Cited by
- 92
- References
- 24
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 5 · 2022: 2 · 2021: 3 · 2018: 2 · 2017: 1 · 2016: 1 · 2015: 3 · 2014: 1 · 2013: 4 · 2012: 5
- FWCI
- 4.94
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- attention deficit hyperactivity disorder, d-amphetamine, Adderall, onset of action, locomotor activity, academic performance, children
- MeSH terms
- Amphetamines, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Dextroamphetamine, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Treatment Outcome
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