Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial
Open accessAbstract
Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD). This randomized placebo-controlled trial of an optimized daily dose of LDX (30, 50 or 70 mg) was conducted in children and adolescents (aged 6-17 years) with ADHD. To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners' Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours). Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment, but the study was not designed to support a statistical comparison between LDX and OROS-MPH. The full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107). At baseline, CPRS-R total scores were similar across treatment groups. At endpoint, differences (active treatment - placebo) in least squares (LS) mean change from baseline CPRS-R total scores were statistically significant (P < 0.001) throughout the day for LDX (effect sizes: 1000 hours, 1.42; 1400 hours, 1.41; 1800 hours, 1.30) and OROS-MPH (effect sizes: 1000 hours, 1.04; 1400 hours, 0.98; 1800 hours, 0.92). Differences in LS mean change from baseline to endpoint were statistically significant (P < 0.001) for both active treatments in all four subscales of the CPRS-R (ADHD index, oppositional, hyperactivity and cognitive). In conclusion, improvements relative to placebo in ADHD-related symptoms and behaviors in children and adolescents receiving a single morning dose of LDX or OROS-MPH were maintained throughout the day and were ongoing at the last measurement in the evening (1800 hours).
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RCTs showed efficacy and tolerability of LDX in child and adolescent ADHD, but each trial had a limited sample size.
“Although randomized controlled trials (RCTs) showed the efficacy and tolerability of LDX in child and adolescent ADHD,10–13 each trial had a limited sample size.”
From Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials (2015) · cites this paper as [13]
The Introduction reports that this randomized trial found LDX effective and well tolerated in children and adolescents with ADHD. The Results (Patient disposition and baseline demographics; page unavailable) give 317 patients in the full analysis set, including 104 receiving LDX. The paper does not characterize its sample size as limited or establish that each of the other cited trials had a limited sample size. (LLM, conf=0.84)
Experimental — accuracy not yet measuredPrevious studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.
“Previous studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.10–13”
From Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials (2015) · cites this paper as [13]
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- Authors
- Coghill, D. R., Banaschewski, T., Lecendreux, M., Zuddas, A., Dittmann, R. W., Otero, I. H., Civil, R., Bloomfield, R., & Squires, L. A.
- Affiliations
- University of Dundee (GB)
- Heidelberg University (DE)
- Hôpital Robert-Debré (FR)
- University of Cagliari (IT)
- Hospital Clínico Universitario Virgen de la Victoria (ES)
- Shire (United Kingdom) (GB)
- Corresponding author
- Coghill, David R.
- ORCID
- Venue
- European Child & Adolescent Psychiatry
- Published
- 2013-05-25
- Volume
- 23
- Issue
- 2
- Pages
- 61-68
- ISSN
- 1018-8827 (ISSN-L)
- 1435-165X
- PMC
- PMC3918120
- OpenAlex
- W2072871224
- Cited by
- 33
- References
- 27
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 4 · 2022: 1 · 2021: 1 · 2020: 5 · 2018: 4 · 2017: 1 · 2016: 5 · 2015: 4 · 2014: 5
- FWCI
- 3.32
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- European Child & Adolescent Psychiatry (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (submittedVersion, cc-by)
- UNICA IRIS Institutional Research Information System (University of Cagliari) (submittedVersion, other-oa)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- University of Oxford
- Deutsche Forschungsgemeinschaft
- Bundesministerium für Bildung und Forschung
- Bundesministerium für Gesundheit
- Vifor Pharma
- H. Lundbeck A/S
- National Institute of Mental Health
- Cilag
- 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 and adolescents, stimulant medication, methylphenidate, osmotic-release oral system, dose optimization
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Parents, Prodrugs, Treatment Outcome
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