title: Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD.
abstract: Methylphenidate (MPH) is widely prescribed for adults with attention deficit hyperactivity disorder (ADHD), but data on long-term treatment and maintenance of effect are lacking. Osmotic release oral system-methylphenidate (OROS-MPH) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension. Efficacy was assessed using the investigator- and subject-rated Conners' Adult ADHD Rating Scales (CAARS:O-SV and CAARS:S-S), and the Clinical Global Impression - Severity (CGI-S), Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects completing ≥52 wk of treatment were eligible for a 4-wk randomized, placebo-controlled withdrawal phase in which loss of treatment effect was assessed using CAARS:O-SV and CGI-S. In the open-label phase (n=156), mean CAARS:O-SV score decreased from baseline by 1.9±7.8 (p<0.01), and small, statistically significant improvements from baseline were observed for CAARS:S-S, CGI-S and SDS. In the double-blind phase (OROS-MPH, n=23; placebo, n=22), CAARS:O-SV increased from double-blind baseline in the OROS-MPH and placebo arms (4.0±7.6 vs. 6.5±7.8, not statistically significant). Long-term OROS-MPH treatment was well tolerated, and there was no evidence of withdrawal or rebound after discontinuation. In conclusion, the short-term benefits of OROS-MPH continue during long-term open-label treatment. Maintenance of efficacy in a placebo-controlled withdrawal design remains to be confirmed in larger patient populations.
authors.affiliation: Department of Cognitive Neuroscience, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
authors.forename: Jan K
authors.initials: JK
authors.lastname: Buitelaar
authors.affiliation: Child and Adolescent Psychiatry, Aschaffenburg, Germany.
authors.forename: Götz-Erik
authors.initials: GE
authors.lastname: Trott
authors.affiliation: Private Practice, Spalenring, Basel, Switzerland.
authors.forename: Maria
authors.initials: M
authors.lastname: Hofecker
authors.affiliation: Janssen-Cilag Europe, Switzerland.
authors.forename: Sandra
authors.initials: S
authors.lastname: Waechter
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Titusville, NJ, USA.
authors.forename: Joris
authors.initials: J
authors.lastname: Berwaerts
authors.affiliation: SGS Life Science Services, Mechelen, Belgium.
authors.forename: Joachim
authors.initials: J
authors.lastname: Dejonkheere
authors.affiliation: Janssen Cilag Medical Affairs Europe, Middle East & Africa, Neuss, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Schäuble
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D013375:Substance Withdrawal Syndrome; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate