Trial reportCNS drugs2018
Cognitive Function of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate.
Trial report in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01328756 (A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Who cites it
10 citing papers in PubMed.
- Efficacy and acceptability of a second dose of ecological executive skills training for children with ADHD: a randomized controlled study and follow-up.European child & adolescent psychiatry · 2021Trial
- Long-term study of lisdexamfetamine dimesylate in Japanese children and adolescents with attention-deficit/hyperactivity disorder.Neuropsychopharmacology reports · 2020Trial
- Differential working memory changes following methylphenidate in medication-naive and medication-experienced adults with ADHD.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Computer-assisted cognitive training in children with developmental disorders: a scoping review of available tools, clinical targets, and evidence gaps.Frontiers in pediatrics · 2026Review
- Differential effects of a single dose of Lisdexamfetamine and Guanfacine on cognitive function in children with ADHD.Frontiers in psychiatry · 2025Article
- Relations between the levels of moderate to vigorous physical activity, BMI, dietary habits, cognitive functions and attention problems in 8 to 9 years old pupils: network analysis (PACH Study).BMC public health · 2024Article
- New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development.Current topics in behavioral neurosciences · 2022Review
- Methods to Develop anFrontiers in psychiatry · 2021Article
- Review
- Computerized cognitive retraining (ReadON.ai) among children diagnosed with attention deficit hyperactivity disorder.Industrial psychiatry journalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSPD489-404 was the first 2-year safety study of lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder in children and adolescents. In accordance with advice from the European Medicines Agency, assessment of cognitive function was a predefined safety outcome in SPD489-404.
objectiveThe objective of this study was to assess cognitive function over 2 years in study SPD489-404, using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
methodsParticipants aged 6-17 years received dose-optimised open-label lisdexamfetamine dimesylate (30, 50 or 70 mg/day) for 104 weeks. Cognition was assessed using four CANTAB tasks; Delayed Matching to Sample (DMS), Spatial Working Memory (SWM), Stop Signal Task (SST) and Reaction Time (RTI). Key and additional variables were pre-specified for each CANTAB task; groupwise mean percentage changes in key variables from baseline of > 5% were considered potentially clinically significant.
resultsAll 314 enrolled participants received lisdexamfetamine dimesylate and were included in the safety population, and 191 (60.8%) completed the study. No potentially clinically significant deteriorations from baseline were observed in any key CANTAB variable over the 2 years of the study. Based on predefined thresholds, potentially clinically significant improvements from baseline were observed at 6 months (DMS median reaction time, mean per cent change, - 6.6%; SWM total between-search errors, - 22.8%; SST stop signal reaction time, -18.9%), and at the last on-treatment assessment (DMS median reaction time, - 6.5%; SWM total between-search errors, - 32.6%; SST stop signal reaction time, - 25.7%).
conclusionsLisdexamfetamine dimesylate treatment for 2 years was not associated with deterioration of cognitive function in children and adolescents with attention-deficit/hyperactivity disorder. Although improvements in some cognitive measures were observed, lack of a control group makes interpretation of the findings difficult. Further studies of the impact of stimulants on cognition are required. CLINICALTRIALS. GOV IDENTIFIER: NCT01328756.
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