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Cited by 34Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesBehavioral and Psychological Studies

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules Administered Once Daily to Children with Attention-Deficit/Hyperactivity Disorder

Childress, Ann C., Spencer, Thomas, Lopez, Frank, Gerstner, Ortrud, Thulasiraman, Anuradha, Muniz, Rafael, Post, Anke·2009·Journal of Child and Adolescent Psychopharmacology
DOI 10.1089/cap.2009.0007
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Abstract

OBJECTIVE: This 5-week, multicenter, double-blind, placebo-controlled, parallel-group investigation is the first fixed-dose study to evaluate efficacy and tolerability of three doses of (10, 20, or 30 mg, once daily [o.d.]) dexmethylphenidate hydrochloride (HCl) extended-release (d-MPH XR; Focalin XR) across multiple settings to treat pediatric attention-deficit/hyperactivity disorder (ADHD). RESULTS: ADHD pediatric outpatients (n = 253) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition, criteria were randomized (1:1:1:1) to receive d-MPH XR (10, 20, or 30 mg o.d.) or placebo. Treatment with d-MPH XR significantly (p < 0.001) reduced the mean score (change from baseline) on Conners'-ADHD/DSM-IV Scales (CADS) as assessed by the teacher CADS-T (dose [mean];10 mg [18], 20 mg [16.9], 30 mg [20.7]) and parents, CADS-P (dose [mean];10 mg [15.8]; 20 mg [17.8]; 30 mg [20.5]) compared to placebo (mean CADS-T [5.7]; CADS-P [4.6]). A significant (p < 0.001) proportion of patients in the three d-MPH XR treatment groups showed improvement on the clinician-rated, Clinical Global Impressions-Improvement (CGI-I) scales (10 mg [73.8%]; 20 mg [71.2%]; 30 mg [77.2 %]) and severity ratings (CGI-S) compared to the placebo group (CGI-I, 22.2%). Adverse events were mild to moderate in severity and similar to previous observations for this class of neurostimulants. CONCLUSION: All three doses of d-MPH XR (10, 20, or 30 mg o.d), were significantly more effective than placebo in improving ADHD symptoms as confirmed by the teacher, parent and clinician. Additionally, d-MPH XR was well tolerated and demonstrated a consistent safety profile.

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  • Dexmethylphenidate has the earliest onset of efficacy of the long-acting preparations.

    “Dexmethylphenidate comes in capsules that can be opened and mixed with food, and has the earliest onset of efficacy of the long-acting preparations [42,43].”

    From Advances in understanding and treating ADHD (2011) · cites this paper as [42]

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Authors
Childress, A. C., Spencer, T., Lopez, F., Gerstner, O., Thulasiraman, A., Muniz, R., & Post, A.
Affiliations
  • Center for Psychiatry and Behavioral Medicine (US)
  • Massachusetts General Hospital (US)
  • Children's Developmental Center, Winter Park, Florida.
  • Novartis (United States) (US)
Corresponding author
Childress, Ann C.
ORCID
Venue
Journal of Child and Adolescent Psychopharmacology
Publisher
SAGE Publications
Published
2009-08
Volume
19
Issue
4
Pages
351-361
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
DOI
10.1089/cap.2009.0007
OpenAlex
W1968113055
Cited by
34
References
31
Citations by year
2026: 1 · 2025: 3 · 2024: 2 · 2023: 5 · 2022: 1 · 2021: 3 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 1 · 2015: 3 · 2013: 2 · 2012: 1
FWCI
1.65
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)
Funders
  • Bristol-Myers Squibb
  • National Institutes of Health
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
Keywords
dexmethylphenidate, sustained-release formulation, attention deficit hyperactivity disorder, children with ADHD, once-daily dosing, fixed-dose comparison, dose comparison, clinical global impression, tolerability, adverse events, stimulant efficacy
MeSH terms
Attention Deficit Disorder with Hyperactivity, Capsules, Child, Delayed-Action Preparations, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Nervous System Diseases, Skin Diseases, Dexmethylphenidate Hydrochloride

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