Cited by 33Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentChild and Adolescent Psychosocial and Emotional Development

The Effects of Lisdexamfetamine Dimesylate on Emotional Lability in Children 6 to 12 Years of Age With ADHD in a Double-Blind Placebo-Controlled Trial

Childress, Ann C., Arnold, Valerie, Adeyi, Ben, Dirks, Bryan, Babcock, Thomas, Scheckner, Brian, Lasser, Robert, Lopez, Frank A.·2014·Journal of Attention Disorders

Abstract

Objective: To evaluate the effect of lisdexamfetamine dimesylate (LDX) on emotional lability (EL) in children with ADHD. Method: Post hoc analyses of a placebo-controlled trial of LDX-stratified children (aged 6-12 years) with ADHD to prominent and not prominent EL at baseline (score >3 or ≤3, respectively, on Conners’ Parent Rating Scale [CPRS] items of anger, loss of temper, and irritability). Efficacy was assessed by change in CPRS EL scores and ADHD Rating Scale-IV (ADHD-RS-IV) total and subscale scores. Safety measures included treatment-emergent adverse events (TEAEs). Results: LDX showed improvement versus placebo ( p < .0005) for EL item least squares (LS) mean change scores at endpoint and throughout the day. At baseline, 138 and 73 participants randomized to LDX treatment and having baseline and endpoint CPRS scores were categorized with CPRS-derived prominent and not prominent baseline EL, respectively; 41 and 31 participants randomized to placebo were categorized with CPRS-derived prominent and not prominent baseline EL, respectively. ADHD-RS-IV total and subscale scores decreased with LDX regardless of baseline EL severity. TEAEs included decreased appetite, insomnia, upper abdominal pain, headache, and irritability. Conclusion: EL and ADHD symptoms improved with LDX regardless of baseline EL symptom severity. LDX demonstrated a safety profile consistent with long-acting psychostimulant use.

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Crossref · 10.1177/1087054712448252

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Authors
Childress, A. C., Arnold, V., Adeyi, B., Dirks, B., Babcock, T., Scheckner, B., Lasser, R., & Lopez, F. A.
Affiliations
  • Center for Psychiatry and Behavioral Medicine (US)
  • University of Tennessee System (US)
  • Shire Development LLC, Wayne, PA, USA
  • Children’s Developmental Center, Winter Park, FL, USA
Venue
Journal of Attention Disorders
Published
2012-06-26
Volume
18
Issue
2
Pages
123-132
ISSN
  • 1087-0547 (ISSN-L)
  • 1557-1246
OpenAlex
W2035130341
Cited by
33
References
27
Citations by year
2025: 2 · 2024: 1 · 2023: 4 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 3 · 2017: 3 · 2016: 1 · 2015: 5 · 2014: 7 · 2013: 2
FWCI
2.88
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Attention Disorders (publishedVersion)
  • PubMed (publishedVersion)
Funders
Vedecká Grantová Agentúra MŠVVaŠ SR a SAV
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
Keywords
lisdexamfetamine dimesylate, emotional lability, attention deficit hyperactivity disorder, children, psychostimulants, irritability, anger, treatment-emergent adverse events, ADHD symptom severity, Conners' Parent Rating Scale, ADHD Rating Scale-IV
MeSH terms
Lisdexamfetamine Dimesylate, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Emotions, Female, Humans, Male, Parents, Personality Assessment, Treatment Outcome, Mood Disorders

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