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Cited by 101Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesDevelopmental and Educational Neuropsychology

A Double-Blind, Placebo-Controlled Trial of Dexmethylphenidate Hydrochloride and d,l-threo-Methylphenidate Hydrochloride in Children With Attention-Deficit/Hyperactivity Disorder

WIGAL, SHARON, SWANSON, JAMES M., FEIFEL, DAVID, SANGAL, R BART, ELIA, JOSEPHINE, CASAT, CHARLES D., ZELDIS, JEROME B., CONNERS, C KEITH·2004·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1097/01.chi.0000138351.98604.92
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Abstract

Objective To evaluate the efficacy and safety of dexmethylphenidate hydrochloride (d-MPH, Focalin) for the treatment of attention-deficit/hyperactivity disorder (ADHD) and to test an a priori hypothesis that d-MPH would have a longer duration of action than d,l-threo-methylphenidate (d,l-MPH).Method This was a randomized, double-blind study conducted at 12 U.S. centers. One hundred thirty-two subjects received d-MPH (n=44), d,l-MPH (n=46), or placebo (n=42) twice daily for 4 weeks, with titration of the dose based on weekly clinic visits. The primary efficacy variable was change from baseline to last study visit on teacher-completed Swanson, Nolan, and Pelham Rating Scale (Teacher SNAP). Secondary efficacy measures included the change on parent-completed SNAP (Parent SNAP), Clinical Global Impressions Scale-Improvement (CGI-I) score, and Math Test performance. Assessments at home in late afternoon were included to test the hypothesis that d-MPH would have a longer duration of efficacy than d,l-MPH. Safety was assessed through monitoring occurrence and severity of adverse events and discontinuations related to them.Results Treatment with either d-MPH (p=.0004) or d,l-MPH (p=.0042) significantly improved Teacher SNAP ratings compared with placebo. The d-MPH group showed significant improvements compared with placebo on the afternoon Parent SNAP ratings (p=.0003) and scores on the Math Test (p=.0236) obtained late in the afternoon at 6:00 p.m. Sixty-seven percent of patients showed improvement on d-MPH and 49% on d,l-MPH based on CGI-I scores. Both d-MPH and d,l-MPH were well tolerated, no patient in the d-MPH group and only two patients each in the d,l-MPH and placebo groups discontinued the study.Conclusions For the treatment of ADHD, an average titrated dose of 18.25 mg/day of d-MPH is as efficacious and safe as an average titrated dose of 32.14 mg/day of d,l-MPH. Both active treatments have large effect sizes. Thus, d-MPH and d,l-MPH appear to provide similar efficacy, and d-MPH may have longer duration of action after twice-daily dosing, but additional studies are needed to determine the statistical and clinical significance of this possibility.

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Authors
WIGAL, S., SWANSON, J. M., FEIFEL, D., SANGAL, R. B., ELIA, J., CASAT, C. D., ZELDIS, J. B., & CONNERS, C. K.
Affiliations
Children's Hospital of Philadelphia (US)
Corresponding author
WIGAL, SHARON
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2004-11
Volume
43
Issue
11
Pages
1406-1414
ISSN
0890-8567 (ISSN-L)
DOI
10.1097/01.chi.0000138351.98604.92
OpenAlex
W1980788399
Cited by
101
References
16
Citations by year
2025: 4 · 2024: 1 · 2023: 4 · 2022: 3 · 2021: 1 · 2019: 1 · 2018: 2 · 2017: 3 · 2016: 3 · 2015: 4 · 2014: 5 · 2013: 3 · 2012: 2
FWCI
5.76
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of the American Academy of Child & Adolescent Psychiatry (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
  • Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
Keywords
dexmethylphenidate, attention deficit hyperactivity disorder, children, duration of action, stimulant efficacy, dose titration, teacher ratings, parent ratings, mathematics achievement, adverse events, Concerta
MeSH terms
Administration, Oral, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Methylphenidate, Placebos, Severity of Illness Index, Stereoisomerism, Treatment Outcome, Dexmethylphenidate Hydrochloride

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