A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder

Rossella Medori, J. Antoni Ramos-Quiroga, Miguel Casas, J. J. S. Kooij, Asko Niemelä, G. tz-Erik Trott, Emma Lee, Jan K. Buitelaar

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. Methods: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. Results: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (≥30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. Conclusions: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics. © 2008 Society of Biological Psychiatry.
Original languageEnglish
Pages (from-to)981-989
JournalBiological Psychiatry
Volume63
Issue number10
DOIs
Publication statusPublished - 2008
Externally publishedYes

Cite this

Medori, Rossella ; Ramos-Quiroga, J. Antoni ; Casas, Miguel ; Kooij, J. J. S. ; Niemelä, Asko ; Trott, G. tz-Erik ; Lee, Emma ; Buitelaar, Jan K. / A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder. In: Biological Psychiatry. 2008 ; Vol. 63, No. 10. pp. 981-989.
@article{f1caa49ba6e74447891030fea9c2bcb5,
title = "A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder",
abstract = "Background: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. Methods: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. Results: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (≥30{\%} decrease) were 50.5{\%}, 48.5{\%}, and 59.6{\%} versus 27.4{\%} (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75{\%}, 76{\%}, and 82{\%} in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66{\%} in placebo; most frequent included decreased appetite (25{\%} methylphenidate; 7{\%} placebo) and headache (21{\%} methylphenidate; 18{\%} placebo). In methylphenidate-treated patients, 4.3{\%} discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. Conclusions: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics. {\circledC} 2008 Society of Biological Psychiatry.",
author = "Rossella Medori and Ramos-Quiroga, {J. Antoni} and Miguel Casas and Kooij, {J. J. S.} and Asko Niemel{\"a} and Trott, {G. tz-Erik} and Emma Lee and Buitelaar, {Jan K.}",
year = "2008",
doi = "10.1016/j.biopsych.2007.11.008",
language = "English",
volume = "63",
pages = "981--989",
journal = "Biological Psychiatry",
issn = "0006-3223",
publisher = "Elsevier USA",
number = "10",

}

A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder. / Medori, Rossella; Ramos-Quiroga, J. Antoni; Casas, Miguel; Kooij, J. J. S.; Niemelä, Asko; Trott, G. tz-Erik; Lee, Emma; Buitelaar, Jan K.

In: Biological Psychiatry, Vol. 63, No. 10, 2008, p. 981-989.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder

AU - Medori, Rossella

AU - Ramos-Quiroga, J. Antoni

AU - Casas, Miguel

AU - Kooij, J. J. S.

AU - Niemelä, Asko

AU - Trott, G. tz-Erik

AU - Lee, Emma

AU - Buitelaar, Jan K.

PY - 2008

Y1 - 2008

N2 - Background: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. Methods: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. Results: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (≥30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. Conclusions: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics. © 2008 Society of Biological Psychiatry.

AB - Background: There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients. Methods: In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed. Results: Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (≥30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5. Conclusions: Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics. © 2008 Society of Biological Psychiatry.

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=42649133116&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/18206857

U2 - 10.1016/j.biopsych.2007.11.008

DO - 10.1016/j.biopsych.2007.11.008

M3 - Article

VL - 63

SP - 981

EP - 989

JO - Biological Psychiatry

JF - Biological Psychiatry

SN - 0006-3223

IS - 10

ER -