 |
|
Randomized, Controlled, Crossover Trial of Methylphenidate in Pervasive Developmental Disorders With Hyperactivity
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.
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
An Update on Autism
Westphal and Volkmar
Focus 2008;6:284-292.
ABSTRACT
| FULL TEXT
Management of Children With Autism Spectrum Disorders
Myers et al.
Pediatrics 2007;120:1162-1182.
ABSTRACT
| FULL TEXT
The Role of Pediatricians Who Care for Children With Autism--Reply
Barbaresi et al.
Arch Pediatr Adolesc Med 2007;161:417-418.
FULL TEXT
Autism: A Review of the State of the Science for Pediatric Primary Health Care Clinicians.
Barbaresi et al.
Arch Pediatr Adolesc Med 2006;160:1167-1175.
ABSTRACT
| FULL TEXT
Methylphenidate hydrochloride reduces hyperactivity in children with pervasive development disorders.
Shea
Evid. Based Ment. Health 2006;9:45-45.
FULL TEXT
Methylphenidate for Children with Autism and Hyperactivity
JWatch Pediatrics 2006;2006:6-6.
FULL TEXT
Methylphenidate for Children with Autism and Hyperactivity
JWatch Pediatrics 2006;2006:9-9.
FULL TEXT
Methylphenidate for Children with Autism and Hyperactivity
JWatch Psychiatry 2006;2006:6-6.
FULL TEXT
|
