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
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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Meta-analyses suggest that stimulants' effect size on diagnostic ADHD symptoms ranges from 0.6 to 0.8.
“meta-analyses suggest a range of 0.6–0.8 [36, 37]”
From Using Stimulants to Treat ADHD-Related Emotional Lability (2014) · cites this paper as [36]
Some studies have reported improvements in EL with stimulant treatment, including MPH.
“some studies have reported improvements in EL with stimulant treatment, including MPH (Baweja et al., 2021; A. C. Childress et al., 2014; López et al., 2017).”
From A Post-Hoc Analysis of Emotional Lability With Delayed-Release/Extended-Release Methylphenidate in Children Aged 6 to 12 Years of Age Participating in Two Phase 3 Clinical Trials (2024) · cites this paper as A. C. Childress et al., 2014
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“Stimulant medications such as methylphenidate (MPH) are known to be effective treatments for ADHD (Biederman et al., 2003) and some studies have reported improvements in EL with stimulant treatment, including MPH (Baweja et al., 2021; A. C. Childress et al., 2014; López et al., 2017).”
BackgroundSelf-citation
- 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
- Publisher
- SAGE Publications
- Published
- 2012-06-26
- Volume
- 18
- Issue
- 2
- Pages
- 123-132
- ISSN
- 1087-0547 (ISSN-L)
- 1557-1246
- OpenAlex
- W2035130341
- Semantic Scholar
- 65bb241295237e3733845687d27292a234e8b210
- 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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