A dose-ranging study of a methylphenidate transdermal system in children with ADHD

W. E. Pelham Jr.; M. J. Manos; C. E. Ezzell; Katy E. Tresco; E. M. Gnagy; M. T. Hoffman; A. N. Onyango; G. A. Fabiano; Katy E. Tresco; null et al.

A dose-ranging study of a methylphenidate transdermal system in children with ADHD

W. E. Pelham Jr., M. J. Manos, C. E. Ezzell, Katy E. Tresco, E. M. Gnagy, M. T. Hoffman, A. N. Onyango, G. A. Fabiano, Katy E. Tresco, et al.

Department of School Psychology

Research output: Contribution to journal › Article › peer-review

Abstract

Objective: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting, further controlled time-course studies will be necessary to evaluate the question of morning onset fully. Â©2005 Journal of the American Academy of Child and Adolescent Psychiatry.

Original language	American English
Journal	Journal of the American Academy of Child and Adolescent Psychiatry
Volume	44
State	Published - Jan 1 2005

Keywords

Administration
Attention Deficit Disorder with Hyperactivity
Attention-deficit/hyperactivity disorder
Central Nervous System Stimulants
Child
Cutaneous
Dose-Response Relationship
Double-Blind Method
Drug
Humans
Long-acting medication
Methylphenidate
Transdermal preparation
Treatment Outcome
anorexia
anxiety
article
attention deficit disorder
clinical article
clinical trial
controlled clinical trial
controlled study
depression
disease severity
double blind procedure
drug dose regimen
drug effect
drug efficacy
drug exposure
erythema
female
hallucination
headache
human
irritability
male
multicenter study
multivariate analysis
priority journal
randomized controlled trial
school child
sleep disorder
social disability
stomach pain
tic

Disciplines

Psychology

Cite this

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title = "A dose-ranging study of a methylphenidate transdermal system in children with ADHD",

abstract = " Objective: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting, further controlled time-course studies will be necessary to evaluate the question of morning onset fully. {\^A}{\textcopyright}2005 Journal of the American Academy of Child and Adolescent Psychiatry.",

keywords = "Administration, Attention Deficit Disorder with Hyperactivity, Attention-deficit/hyperactivity disorder, Central Nervous System Stimulants, Child, Cutaneous, Dose-Response Relationship, Double-Blind Method, Drug, Humans, Long-acting medication, Methylphenidate, Transdermal preparation, Treatment Outcome, anorexia, anxiety, article, attention deficit disorder, clinical article, clinical trial, controlled clinical trial, controlled study, depression, disease severity, double blind procedure, drug dose regimen, drug effect, drug efficacy, drug exposure, erythema, female, hallucination, headache, human, irritability, male, multicenter study, multivariate analysis, priority journal, randomized controlled trial, school child, sleep disorder, social disability, stomach pain, tic",

author = "{Pelham Jr.}, {W. E.} and Manos, {M. J.} and Ezzell, {C. E.} and Tresco, {Katy E.} and Gnagy, {E. M.} and Hoffman, {M. T.} and Onyango, {A. N.} and Fabiano, {G. A.} and Tresco, {Katy E.} and {et al.}",

year = "2005",

month = jan,

day = "1",

language = "American English",

volume = "44",

journal = "Journal of the American Academy of Child and Adolescent Psychiatry",

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T1 - A dose-ranging study of a methylphenidate transdermal system in children with ADHD

AU - Pelham Jr., W. E.

AU - Manos, M. J.

AU - Ezzell, C. E.

AU - Tresco, Katy E.

AU - Gnagy, E. M.

AU - Hoffman, M. T.

AU - Onyango, A. N.

AU - Fabiano, G. A.

AU - Tresco, Katy E.

AU - et al., null

PY - 2005/1/1

Y1 - 2005/1/1

N2 - Objective: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting, further controlled time-course studies will be necessary to evaluate the question of morning onset fully. Â©2005 Journal of the American Academy of Child and Adolescent Psychiatry.

AB - Objective: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. Method: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. Results: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. Conclusions: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting, further controlled time-course studies will be necessary to evaluate the question of morning onset fully. Â©2005 Journal of the American Academy of Child and Adolescent Psychiatry.

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KW - Long-acting medication

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KW - drug dose regimen

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KW - irritability

KW - male

KW - multicenter study

KW - multivariate analysis

KW - priority journal

KW - randomized controlled trial

KW - school child

KW - sleep disorder

KW - social disability

KW - stomach pain

KW - tic

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M3 - Article

VL - 44

JO - Journal of the American Academy of Child and Adolescent Psychiatry

JF - Journal of the American Academy of Child and Adolescent Psychiatry

ER -

A dose-ranging study of a methylphenidate transdermal system in children with ADHD

Abstract

Keywords

Disciplines

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