Cognitive function of children and adolescents with attention-deficit/hyperactivity disorder in a 2-year open-label study of lisdexamfetamine dimesylate
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 outco...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
30 January 2018
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| In: |
CNS drugs
Year: 2018, Volume: 32, Issue: 1, Pages: 85-95 |
| ISSN: | 1179-1934 |
| DOI: | 10.1007/s40263-017-0487-z |
| Online Access: | Verlag, Volltext: https://doi.org/10.1007/s40263-017-0487-z
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| Author Notes: | David R. Coghill, Tobias Banaschewski, Caleb Bliss, Brigitte Robertson, Alessandro Zuddas |
| Summary: | 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 identifierNCT01328756. |
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| Item Description: | Gesehen am 27.05.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1179-1934 |
| DOI: | 10.1007/s40263-017-0487-z |