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Cited by 45Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Effectiveness, Safety, and Tolerability of Lisdexamfetamine Dimesylate in Children With Attention-Deficit/Hyperactivity Disorder: An Open-Label, Dose-Optimization Study

Findling, Robert L., Ginsberg, Lawrence D., Jain, Rakesh, Gao, Joseph·2009·Journal of Child and Adolescent Psychopharmacology
DOI 10.1089/cap.2008.0165
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Abstract

OBJECTIVE: The aim of this study was to assess the effectiveness and safety of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: This was a 7-week, open-label study evaluating 20, 30, 40, 50, 60, or 70 mg/day LDX in 318 children aged 6-12 years with ADHD. The ADHD Rating Scale IV (ADHD-RS-IV) was the primary efficacy assessment. Secondary measures included the Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children (EESC), and Behavior Rating Inventory of Executive Function (BRIEF). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms. RESULTS: At end point, mean (standard deviation [SD]) improvement from baseline in ADHD-RS-IV total score was 28.6 (10.9) (p < 0.0001). Most subjects (89.9%) were rated "improved" (i.e., CGI-I 1 or 2). Improvements from baseline were observed in the EESC total and subscale scores (p < or = 0.0002). LDX treatment resulted in significant improvement on the Global Executive Composite, Behavioral Regulation, and Metacognition indices of the BRIEF (p < 0.0001). TEAEs (incidences > or =10%) were decreased appetite, decreased weight, irritability, insomnia, headache, upper abdominal pain, and initial insomnia. CONCLUSIONS: LDX was effective and generally well tolerated with a safety profile consistent with long-acting stimulant use. There was overall improvement in ADHD symptoms and executive function measures and no worsening of emotional expression measures. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00500071.

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  • In that study, a 12-year-old girl with a prior history of intermittent syncope experienced a syncopal episode on lisdexamfetamine 60 mg that was considered a serious adverse event, but she completed the study successfully.

    “The first occurred in a 12-year-old girl with a prior history of intermittent syncope who experienced a syncopal episode on lisdexamfetamine 60 mg that was considered a serious adverse event, but she went on to complete the study successfully.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [22]

  • In Findling et al open-label 7-week dose-optimization study of 318 children, lisdexamfetamine was well tolerated and produced statistically significant improvements on ADHD-RS-IV, CGI, Parent Global Assessment, BRIEF, and EESC scales.

    “Lisdexamfetamine was well tolerated throughout this study. Statistically significant (P < 0.001) improvements on the ADHD-RS-IV scale were found, as well as improvements on the CGI, Parent Global Assessment, Behavior Rating Inventory of Executive Function (BRIEF), and Expression and Emotion Scale for Children (EESC) scales.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [22]

  • Despite these two serious adverse events, high levels of satisfaction with medication were reported by parents on the Medication Satisfaction Questionnaire during the trial.

    “Despite these two serious adverse events, high levels of satisfaction with medication were reported by parents on the Medication Satisfaction Questionnaire during the trial.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [22]

  • In that study, a 7-year-old boy with an implanted loop recorder after a prior near-drowning incident had a sinus arrest of 6 seconds while on lisdexamfetamine 30 mg; it was determined to be unrelated to lisdexamfetamine and he was discontinued from the study.

    “The second serious adverse event occurred in a 7-year-old boy with an implanted loop recorder after a prior near-drowning incident, who was noted to have a sinus arrest of 6 seconds while on lisdexamfetamine 30 mg. Although this was determined to be unrelated to lisdexamfetamine, the subject was discontinued from the study.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [22]

  • LDX demonstrated small but statistically significant improvements in emotional lability on the clinician-administered, parent/caregiver-reported EESC total and subscale scores in children with ADHD.

    “LDX demonstrated small but statistically significant improvements in emotional lability on the clinician-administered, parent/caregiver-reported EESC total and subscale (positive emotions, emotional flatness, and emotional lability) scores (Findling et al. 2009).”

    From Treatment Outcomes with Lisdexamfetamine Dimesylate in Children Who Have Attention-Deficit/Hyperactivity Disorder with Emotional Control Impairments (2013) · cites this paper as Findling et al. 2009

Cites

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Research works printed but not linked: 6

  1. Doyle AE, 2006, J Clin Psychiatry, 67, 21
  2. Faraone SV, 2003, World Psychiatry, 2, 104
  3. Qian Y, 2007, Beijing Da Xue Xue Bao, 39, 277
  4. Qian Y, 2007, Beijing Da Xue Xue Bao, 39, 299
  5. Strine TW, 2006, Prev Chronic Dis, 3, 1
  6. Swanson JM, 2003, J Clin Psychiatry, 64, 35

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Authors
Findling, R. L., Ginsberg, L. D., Jain, R., & Gao, J.
Affiliations
  • University Hospitals Cleveland Medical Center (US)
  • Red Oak Psychiatry Associates, Houston, Texas.
  • R/D Clinical Research, Inc., Lake Jackson, Texas.
  • Takeda (United States) (US)
Corresponding author
Findling, Robert L.
Venue
Journal of Child and Adolescent Psychopharmacology
Publisher
SAGE Publications
Published
2009-12
Volume
19
Issue
6
Pages
649-662
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
DOI
10.1089/cap.2008.0165
OpenAlex
W1996061461
Cited by
45
References
39
Citations by year
2023: 2 · 2021: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 3 · 2014: 5 · 2013: 10 · 2012: 3
FWCI
3.33
Type
journal article
Language
en
Open access
closed
Licence
www.liebertpub.com/nv/resources-tools/text-and-data-mining-policy/121/ (tdm)
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, children, dose optimization, stimulant medication, ADHD-RS-IV, executive function, emotional expression, treatment-emergent adverse events, tolerability, long-acting stimulants
MeSH terms
Lisdexamfetamine Dimesylate, Central Nervous System Stimulants, Appetite, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Electrocardiography, Female, Humans, Male, Prodrugs, Psychiatric Status Rating Scales, Severity of Illness Index, Weight Loss, Treatment Outcome, Patient Satisfaction, Expressed Emotion, Executive Function

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