Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study
Open accessAbstract
OBJECTIVE: To assess the effects of lisdexamfetamine dimesylate (LDX) on executive function (EF) behaviors in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This observational, open-label, 7-week, dose-optimization study of LDX (20-70 mg/day) in children with ADHD evaluated efficacy with the ADHD Rating Scale IV; safety measures included adverse events (AEs). EF was assessed with the Behavior Rating Inventory of Executive Function (BRIEF). Post hoc analyses examined BRIEF scores by sex, ADHD subtype, comorbid psychiatric symptoms, and common treatment-emergent AEs (TEAEs). ADHD Rating Scale IV scores were assessed in subjects categorized by baseline BRIEF global executive composite T scores with clinically significant (≥65) or not clinically significant (<65) impairment in EF. RESULTS: Mean (standard deviation) change from baseline to endpoint for BRIEF of -17.9 (12.5) for Global Executive Composite, -15.4 (12.6) for Behavioral Regulation Index, and -17.6 (12.3) for Metacognition Index demonstrated improvement with LDX (pooled doses; p < 0.0001 for all). Improvements in BRIEF scores were seen regardless of sex, ADHD subtype, comorbid psychiatric symptoms, common TEAEs, or baseline EF impairment category. TEAEs included decreased appetite, decreased weight, irritability, insomnia, headache, upper abdominal pain, and initial insomnia. CONCLUSIONS: Improvements were demonstrated in EF behaviors and ADHD symptoms with LDX. LDX safety profile was consistent with long-acting stimulant use.
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In Turgay et al 7-week open-label study of 319 children aged 6-12 years with ADHD, lisdexamfetamine produced significant improvements in ADHD-RS-IV, BRIEF, and EESC scores.
“In a 7-week, open-label study of 319 children (6–12 years) with ADHD, Turgay et al35 found significant improvements in ADHD-RS-IV, BRIEF, and EESC scores.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [35]
The Methods describe a 7-week open-label lisdexamfetamine study in children aged 6–12 with ADHD. The Results report significant improvements in ADHD-RS-IV, BRIEF, and EESC scores, but our copy does not establish the claimed total of 319 children: it reports 317 in the safety population and 308 with baseline and endpoint BRIEF measurements. (LLM, conf=0.85)
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- Authors
- Turgay, A., Ginsberg, L., Sarkis, E., Jain, R., Adeyi, B., Gao, J., Dirks, B., Babcock, T., Scheckner, B., Richards, C., Lasser, R., & Findling, R. L.
- Affiliations
- University of Toronto (CA)
- Red Oak Psychiatry Associates, Houston, Texas.
- Sarkis Clinical Trials, Gainesville, Florida.
- R/D Clinical Research, Inc., Lake Jackson, Texas.
- Takeda (United States) (US)
- University Hospitals Cleveland Medical Center (US)
- Corresponding author
- Findling, Robert L.
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2010-12
- Volume
- 20
- Issue
- 6
- Pages
- 503-511
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- PMC
- PMC3005278
- OpenAlex
- W2046461248
- Cited by
- 23
- References
- 53
- Citations by year
- 2025: 2 · 2024: 2 · 2023: 2 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 1 · 2014: 2 · 2013: 3 · 2012: 5
- FWCI
- 1.75
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Abbott Laboratories
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Purdue University
- University of Ottawa
- Jazz Pharmaceuticals
- Neurocrine Biosciences
- Supernus Pharmaceuticals
- Purdue Pharma
- Hospital for Sick Children
- H. Lundbeck A/S
- Medical Research Council
- UCB Pharma
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, executive function, children, long-acting stimulants, BRIEF, ADHD Rating Scale-IV, treatment-emergent adverse events, ADHD subtypes, comorbid psychiatric symptoms, dose optimization
- MeSH terms
- Lisdexamfetamine Dimesylate, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Female, Humans, Male, Neuropsychological Tests, Prospective Studies, Psychometrics, Executive Function
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