A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

Wigal, Sharon B.; Kollins, Scott H.; Childress, Ann; Squires, Liza A.

doi:10.1186/1753-2000-3-17

Cited by 101 publications

(146 citation statements)

References 24 publications

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“…TEAEs of highest incidence included decreased appetite, decreased weight, irritability, and insomnia. The incidence, profile, and severity of TEAEs were similar to those reported in other recent studies of LDX in children with ADHD (Biederman et al 2007a(Biederman et al , 2007bFindling et al 2008;Wigal et al 2009) Steele et al 2006). In general, LDX demonstrated a safety profile consistent with that of long-acting stimulant use.…”

Section: Discussionsupporting

confidence: 87%

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Turgay

Ginsberg²,

Sarkis³

et al. 2010

Journal of Child and Adolescent Psychopharmacology

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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 À17.9 (12.5) for Global Executive Composite, À15.4 (12.6) for Behavioral Regulation Index, and À17.6 (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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Section: Discussionsupporting

confidence: 87%

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Turgay

Ginsberg²,

Sarkis³

et al. 2010

Journal of Child and Adolescent Psychopharmacology

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“…It incorporates assessments commonly used in clinical trials of ADHD, such as ratings by parents and teachers, persistent effort on grade-level math tests, and observer ratings of attention and deportment. In this study, we seek to capitalize upon the strengths of the laboratory school design, which has contributed to the clinical understanding of medicines approved for the treatment of ADHD (Swanson et al 2000(Swanson et al , 2002McCracken et al 2003;Wigal et al 2003Wigal et al , 2009.…”

Section: Introductionmentioning

confidence: 99%

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Wigal

Wigal²,

Schuck³

et al. 2011

Journal of Child and Adolescent Psychopharmacology

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Objective: To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in children with attention-deficit/hyperactivity disorder (ADHD). Methods: This double-blind, randomized, placebo-controlled, crossover laboratory school study enrolled 78 children aged 9-12 years with ADHD who responded to OROS MPH. After determining individualized OROS MPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROS MPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week. Primary efficacy was measured by Permanent Product Measure of Performance at 4 hours after study drug administration. Results: Treatment with OROS MPH resulted in statistically significant improvement in Permanent Product Measure of Performance and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores, measures of response time, and of working memory compared to placebo. Other measures did not meet all pre-established criteria for significance (maintenance of the overall type I error rate at 5%). Adverse events were consistent with previous reports of stimulant medications used in the management of ADHD. There were no discontinuations due to adverse events, and no serious adverse events or deaths. Conclusions: OROS MPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo. Adverse effects reported were consistent with prior studies. Clinical Trial Registry Information: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of Concerta on Older Children with ADHD, URL: http://clinicaltrials.gov/ct2/ show/NCT00799409, unique identifier: NCT00799409.

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“…Another study reported beneficial effects of LDX lasting from 1.5 to 13 hours post-dose 29 . In a 4-week, double-blind, randomized study in children, the evening rebound associated with LDX proved to be less than with placebo (2.9% vs 9.7%, respectively) 30 .…”

Section: Pharmacokineticsmentioning

confidence: 99%

“…In a laboratory classroom study in 117 school-children, LDX provided therapeutic efficacy in as little as 1.5 hours after administration and the effects were maintained for up to 13 hours post-dose (last time point evaluated) 29 . Compared with placebo, significantly greater efficacy (P < 0.005) was found in the SKAMP and Permanent Product Measure of Performance scores with LDX at 1.5 and 13 hours post-dose 29 . The long-term efficacy of LDX was demonstrated in an 11-month open-label study involving 272 children 34 .…”

Section: Efficacymentioning

confidence: 99%

Lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder: pharmacokinetics, efficacy and safety in children and adolescents

Mattos

2014

Rev. psiquiatr. clín.

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Background: Psychostimulants (methylphenidate and amphetamines) are considered first-line therapy for attention-deficit/hyperactivity disorder (ADHD). Lisdexamfetamine dimesylate (LDX) is a new psychostimulant approved for the treatment of ADHD in Brazil. The pharmacologically active fraction, d-amphetamine, is gradually released by hydrolysis of the LDX prodrug. Objectives: To perform a systematic review of the literature of the efficacy and safety of LDX in the treatment of ADHD in children and adolescents. Methods: Medline/PubMed searches for "d-amfetamine", "lisdexamfetamine" and "lisdexamfetamine dimesylate" were conducted including articles available from January 2000 to November 2013. Additional references were identified using references listed in those articles. Further data on LDX were requested from its manufacturer. Results: Thirty-one papers were found related to ADHD treatment in children and adolescents. Discussion: The therapeutic benefits of LDX in children with ADHD are achieved as early as 1.5 hours after its administration and last for up to 13 hours, with efficacy comparable or superior to that of other available psychostimulants. The literature also reports efficacy in long-term treatment, with safety and tolerability profiles comparable to those of other stimulants used for the treatment of ADHD. Most of the adverse events associated with LDX are considered to be mild or moderate in severity, with the most common being loss of appetite and insomnia.

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A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

Cited by 101 publications

References 24 publications

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder: pharmacokinetics, efficacy and safety in children and adolescents

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A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

Cited by 101 publications

References 24 publications

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Executive Function Deficits in Children with Attention-Deficit/Hyperactivity Disorder and Improvement with Lisdexamfetamine Dimesylate in an Open-Label Study

Academic, Behavioral, and Cognitive Effects of OROS® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder

Lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder: pharmacokinetics, efficacy and safety in children and adolescents

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Product

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Academic, Behavioral, and Cognitive Effects of OROS^® Methylphenidate on Older Children with Attention-Deficit/Hyperactivity Disorder