Efficacy and Duration of Effect of Extended-Release Dexmethylphenidate Versus Placebo in Schoolchildren With Attention-Deficit/Hyperactivity Disorder

Silva, Raul R.; Muniz, Rafael; Pestreich, Linda; Childress, Ann; Brams, Matthew; Lopez, Frank A.; Wang, James

doi:10.1089/cap.2006.16.239

Cited by 44Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesDevelopmental and Educational Neuropsychology

Efficacy and Duration of Effect of Extended-Release Dexmethylphenidate Versus Placebo in Schoolchildren With Attention-Deficit/Hyperactivity Disorder

Silva, Raul R., Muniz, Rafael, Pestreich, Linda, Childress, Ann, Brams, Matthew, Lopez, Frank A., Wang, James·2006·Journal of Child and Adolescent Psychopharmacology

DOI 10.1089/cap.2006.16.239

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Abstract

Objective The aim of this study was to assess changes in symptomatology of attention-deficit/ hyperactivity disorder (ADHD) with extended-release dexmethylphenidate (d-MPHER) versus placebo in a laboratory classroom setting. Methods This double-blind, placebo-controlled, crossover study randomized 54 children 6-12 years of age, stabilized on methylphenidate 20-40 mg/day. Patients participated in a practice day, then received 5 days of treatment with d-MPH-ER 20 mg/day or placebo. After a 1-day wash-out, they returned to the classroom and received 1 dose of their assigned treatment. Evaluations occurred predose and at postdose hours 1, 2, 4, 6, 8, 9, 10, 11, and 12. Children were then crossed over to the alternate treatment, using identical protocol. Primary efficacy variable was the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP)-Combined scores, and primary analysis time point was 1 hour postdose; secondary efficacy variables over 12 hours included SKAMP-Attention and -Deportment scores and written math test results. Safety was assessed by adverse event (AE) recording following each period. Vital signs were recorded at each visit; laboratory tests were conducted at screening and final visit. Results D-MPH-ER 20 mg/day showed a significant advantage over placebo as early as 1 hour postdose on SKAMP-Combined scores (p Conclusions D-MPH-ER is safe and effective and improves classroom attention, deportment, and performance in children with ADHD.

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Treatment of Children with Attention-Deficit/Hyperactivity Disorder: Results of a Randomized, Multicenter, Double-Blind, Crossover Study of Extended-Release Dexmethylphenidate and D,L-Methylphenidate and Placebo in a Laboratory Classroom Setting
Silva, R., MD, Muniz, R., MD, McCague, K., A, M., Childress, A. C., MD, Brams, M. N., MD, et al. (2025) · Psychopharmacology Bulletin · doi:10.64719/pb.4276 · Cited by 27 · see citing works
Self-citation
Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
Greenhill, L. L., Muniz, R., BALL, R. R., Levine, A. J., Pestreich, L. K., & Jiang, H. (2006) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000220847.41027.5d · Cited by 63 · see citing works
Self-citation
A Randomized, Double-Blind, Crossover Study of Once-Daily Dexmethylphenidate in Children with Attention-Deficit Hyperactivity Disorder
Brams, M. N., Muniz, R., Childress, A. C., Giblin, J. M., Mao, A. R., Turnbow, J. M., Borrello, M., McCague, K., López, F. A., & Silva, R. (2008) · CNS Drugs · doi:10.2165/00023210-200822080-00006 · Cited by 42 · see citing works
Self-citation

Authors: Silva, R. R., Muniz, R., Pestreich, L., Childress, A., Brams, M., Lopez, F. A., & Wang, J.
Affiliations: New York University (US)
Novartis (United States) (US)
Nevada Behavioral Health, Inc., Las Vegas, Nevada.
Bayou City Research, Houston, Texas.
Children’s Development Center, Maitland, Florida.
ORCID: Muniz, Rafael
Childress, Ann
Brams, Matthew
Wang, James
Venue: Journal of Child and Adolescent Psychopharmacology
Publisher: SAGE Publications
Published: 2006-06
Volume: 16
Issue: 3
Pages: 239-251
ISSN: 1044-5463 (ISSN-L)
1557-8992
DOI: 10.1089/cap.2006.16.239
OpenAlex: W2030446955
Cited by: 44
References: 30
Citations by year: 2025: 2 · 2023: 2 · 2018: 1 · 2017: 1 · 2016: 2 · 2015: 3 · 2013: 2 · 2012: 6
FWCI: 2.97
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
Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
Keywords: attention deficit hyperactivity disorder, methylphenidate, stimulant medication, elementary school students, classroom attention, deportment, mathematics achievement, drug efficacy, drug safety, adverse events
MeSH terms: Central Nervous System Stimulants, Aptitude Tests, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Mathematics, Methylphenidate, Psychiatric Status Rating Scales, Treatment Outcome, Cross-Over Studies, Dexmethylphenidate Hydrochloride

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Efficacy and Duration of Effect of Extended-Release Dexmethylphenidate Versus Placebo in Schoolchildren With Attention-Deficit/Hyperactivity Disorder

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