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

Ann C. Childress, Valerie Arnold, Ben Adeyi, Bryan Dirks, Thomas Babcock, Brian Scheckner, Robert Lasser, Frank A. Lopez

Research output: Contribution to journalArticle

15 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)123-132
Number of pages10
JournalJournal of Attention Disorders
Volume18
Issue number2
DOIs
StatePublished - Feb 1 2014

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Placebos
Safety
Anger
Sleep Initiation and Maintenance Disorders
Appetite
Lisdexamfetamine Dimesylate
Least-Squares Analysis
Abdominal Pain
Headache
Therapeutics

All Science Journal Classification (ASJC) codes

  • Developmental and Educational Psychology
  • Clinical Psychology

Cite this

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.

In: Journal of Attention Disorders, Vol. 18, No. 2, 01.02.2014, p. 123-132.

Research output: Contribution to journalArticle

Childress, Ann C. ; Arnold, Valerie ; Adeyi, Ben ; Dirks, Bryan ; Babcock, Thomas ; Scheckner, Brian ; Lasser, Robert ; Lopez, Frank A. / 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. In: Journal of Attention Disorders. 2014 ; Vol. 18, No. 2. pp. 123-132.
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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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