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Research Units on Pediatric Psychopharmacology (RUPP) Autism Network

Arch Gen Psychiatry. 2005;62:1266-1274.

Context  Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive.

Objectives  To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity.

Design  Double-blind, placebo-controlled, crossover trial followed by open-label continuation.

Setting  Five academic outpatient clinics.

Participants  Seventy-two drug-free children, aged 5 to 14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity.

Interventions  Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days. The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses. Subjects who tolerated the test dose (n = 66) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase. Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose.

Main Outcome Measures  The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist. Response was defined as "much improved" or "very much improved" on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score.

Results  Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater. Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders. Adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects.

Conclusions  Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder. Adverse effects were more frequent.

Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Participants: Michael G. Aman, PhD, (principal investigator), L. Eugene Arnold, MEd, MD, Yaser Ramadan, MD, Andrea Witwer, BS, and Ronald Lindsay, MD, The Ohio State University, Columbus; Christopher J. McDougle, MD, (principal investigator), David J. Posey, MD, Naomi Swiezy, PhD, and Arlene Kohn, BA, Indiana University, Indianapolis; James T. McCracken, MD, (principal investigator), Bhavik Shah, MD, Pegeen Cronin, PhD, James McGough, MD, and Lisa Sea-Yun Lee, BA, University of California, Los Angeles; Lawrence Scahill, MSN, PhD, (principal investigator), Andres Martin, MD, Kathleen Koenig, MSN, Deirdre Carroll, MSN, Christopher Young, MD, and Allison Lancor, BA, Yale University, New Haven, Conn; Elaine Tierney, MD (principal investigator), Jaswinder Ghuman, MD, Nilda M. Gonzalez, MD, and Marco Grados, MD, Kennedy Krieger Institute, Baltimore, Md; Benedetto Vitiello, MD (principal investigator), and Louise Ritz, MBA, National Institute of Mental Health, Bethesda, Md; statistical analysis: Shirley Chuang, MS, and Mark Davies, MPH, Columbia University, New York, NY; and data management: James Robinson, MEd, and Don McMahon, MS, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY.

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