Cited by 68Attention Deficit Hyperactivity DisorderObsessive-Compulsive Spectrum DisordersPharmaceutical studies and practices

Emergence of Tics in Children with ADHD: Impact of Once-Daily OROS® Methylphenidate Therapy

Palumbo, Donna, Spencer, Thomas, Lynch, Joseph, Co-Chien, Harvey, Faraone, Stephen V.·2004·Journal of Child and Adolescent Psychopharmacology

Abstract

OBJECTIVES: While stimulants are the recognized first-line choice of pharmacotherapy for ADHD, reports that they may induce or exacerbate tics have tended to limit their use in ADHD children who have a history of tics or a family history of Tourette's syndrome. This study analyzes the incidence of tics reported across five studies of children with ADHD who received methylphenidate (MPH)-based therapy as part of the clinical development program for once-daily OROS MPH (CONCERTA McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA). METHODS: Data were analyzed from three placebo-controlled, active-controlled studies (studies 1-3) lasting 1-4 weeks, and two open-label studies lasting 2 years (study 4) and 9 months (study 5), respectively. During the course of the studies, parents were asked at the end of each week of treatment (studies 1 and 2), biweekly (study 3), or monthly (for the first year of study 4, then at 3-month intervals thereafter) whether their child had experienced tics. Tics could also be reported as adverse events in the two open-label studies. RESULTS: Pooled data from the three placebo-controlled studies showed that the incidence of tics was not significantly different across all three treatment groups (OROS MPH, 4.0%; MPH tid, 2.3%; placebo, 3.7%, p = 0.5249). During the first year of the 2-year open-label study, the monthly incidence of tics remained constant, at approximately 5%. Analysis of tic episodes per patient in this study found no correlation between an OROS MPH dose and the frequency of tic episodes. The risk of tic episodes was higher in patients with a history of tics than in those with no history of tics (33% versus 7%, p < 0.0001). However, only 2 children with a history of tics (4%) withdrew from therapy because of their tics. CONCLUSIONS: These data suggest that MPH-based therapy does not significantly induce or exacerbate tics in children with ADHD.

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Crossref · 10.1089/1044546041649138

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Authors
Palumbo, D., Spencer, T., Lynch, J., Co-Chien, H., & Faraone, S. V.
Affiliations
  • University of Rochester Medicine (US)
  • Harvard University (US)
  • McNeil Consumer &amp; Specialty Pharmaceuticals, Fort Washington, Pennsylvania.
  • Alza Corporation, Mountain View, California. This study was funded by McNeil Consumer &amp; Specialty Pharmaceuticals, Fort Washington, Pennsylvania.
Venue
Journal of Child and Adolescent Psychopharmacology
Published
2004-06
Volume
14
Issue
2
Pages
185-194
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
OpenAlex
W2031896587
Cited by
67
References
35
Citations by year
2024: 1 · 2023: 1 · 2022: 1 · 2021: 3 · 2019: 1 · 2017: 2 · 2016: 4 · 2014: 4 · 2012: 2
FWCI
3.53
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
attention deficit hyperactivity disorder, tics, methylphenidate, OROS methylphenidate, Concerta, stimulant pharmacotherapy, Tourette syndrome, children, adverse events, dose-response relationship
MeSH terms
Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Methylphenidate, Verbal Behavior, Cross-Over Studies, Tics

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