PMID- 17028508
OWN - NLM
STAT- MEDLINE
DCOM- 20070625
LR  - 20220311
IS  - 0890-8567 (Print)
IS  - 0890-8567 (Linking)
VI  - 45
IP  - 11
DP  - 2006 Nov
TI  - Safety and tolerability of methylphenidate in preschool children with ADHD.
PG  - 1294-1303
LID - S0890-8567(09)61911-0 [pii]
LID - 10.1097/01.chi.0000235082.63156.27 [doi]
AB  - OBJECTIVE: To report on the safety and tolerability of methylphenidate (MPH) 3- 
      to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) 
      during 1 year of treatment. METHOD: Exactly 183 children (3-5 years old) entered 
      a treatment study of MPH, consisting of a 1-week open-label lead-in (n=183); a 
      5-week placebo-controlled, double-blind phase (n=165); a 5-week double-blind, 
      parallel phase (n=114); and 10 months of open-label maintenance (n=140 entered, 
      95 completed). Mean total daily MPH doses rose from the titration trial best 
      dose, 14.1 (+/-8.1) mg/day, to 20.5 (+/-9.7) mg/day mean total daily dose at the 
      end of maintenance. Pulse, blood pressure, and the presence of treatment emergent 
      adverse events (AEs), parent and teacher AE ratings, and vital signs were 
      recorded in each phase. RESULTS: Thirty percent of parents spontaneously reported 
      moderate to severe AEs in all study phases after baseline. These included 
      emotional outbursts, difficulty falling asleep, repetitive behaviors/thoughts, 
      appetite decrease, and irritability. During titration, decreased appetite 
      (chi=5.4, p<.03), trouble sleeping (chi=5.4, p<.03), and weight loss (chi=4.0, 
      p<.05) occurred statistically more often on MPH than on placebo. During 
      maintenance, trouble sleeping and appetite loss persisted and other MPH-related 
      AEs decreased. There were transient, one-time pulse and blood pressure elevations 
      in five children. Twenty-one children (11%) discontinued because of 
      drug-attributed AEs. CONCLUSIONS: Eleven percent of preschoolers discontinued 
      treatment because of intolerable MPH AEs. Of the serious AEs reported, one 
      occurred in baseline, two in lead-in, three in titration, one in parallel, and 
      one in maintenance. Only one was possibly related to MPH.
FAU - Wigal, Tim
AU  - Wigal T
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Greenhill, Laurence
AU  - Greenhill L
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.. Electronic address: larrylgreenhill@cs.com.
FAU - Chuang, Shirley
AU  - Chuang S
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - McGOUGH, James
AU  - McGOUGH J
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Vitiello, Benedetto
AU  - Vitiello B
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Skrobala, Anne
AU  - Skrobala A
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Swanson, James
AU  - Swanson J
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Wigal, Sharon
AU  - Wigal S
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Abikoff, Howard
AU  - Abikoff H
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Kollins, Scott
AU  - Kollins S
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - McCRACKEN, James
AU  - McCRACKEN J
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Riddle, Mark
AU  - Riddle M
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Posner, Kelly
AU  - Posner K
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Ghuman, Jaswinder
AU  - Ghuman J
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Davies, Mark
AU  - Davies M
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Thorp, Ben
AU  - Thorp B
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
FAU - Stehli, Annamarie
AU  - Stehli A
AD  - Drs. T. Wigal, S. Wigal, Stehli, Thorp, and Swanson are with the University of 
      California, Irvine; Dr. Abikoff is with the New York University Child Study 
      Center, New York; Drs. McCracken and McGough are with the University of 
      California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; 
      Dr. Kollins is with Duke University Medical Center; Durham, NC; Drs. Greenhill, 
      Chuang, and Posner, Ms. Skrobala, and Mr. Davies are with New York State 
      Psychiatric Institute/Columbia University, New York; Dr. Vitiello is with the 
      National Institute of Mental Health, Bethesda, MD; and Dr. Ghuman is with the 
      University of Arizona, Tucson.
LA  - eng
GR  - K23 MH001883-05/MH/NIMH NIH HHS/United States
GR  - U01 MH60943/MH/NIMH NIH HHS/United States
GR  - U01 MH60900/MH/NIMH NIH HHS/United States
GR  - U01 MH60903/MH/NIMH NIH HHS/United States
GR  - U01 MH60642/MH/NIMH NIH HHS/United States
GR  - U01 MH60833/MH/NIMH NIH HHS/United States
GR  - U01 MH60848/MH/NIMH NIH HHS/United States
PT  - Comment
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 0 (Central Nervous System Stimulants)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-93. PMID: 17023867
CON - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-93. PMID: 17023867
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-13. PMID: 17023868
CON - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-13. PMID: 17023868
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-83. PMID: 17023869
CON - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-83. PMID: 17023869
CIN - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-22. PMID: 17023870
CON - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-22. PMID: 17023870
MH  - Anorexia/chemically induced
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/*adverse effects/therapeutic use
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylphenidate/*adverse effects/therapeutic use
MH  - Sleep Wake Disorders/chemically induced
EDAT- 2006/10/10 09:00
MHDA- 2007/06/26 09:00
CRDT- 2006/10/10 09:00
PHST- 2006/10/10 09:00 [pubmed]
PHST- 2007/06/26 09:00 [medline]
PHST- 2006/10/10 09:00 [entrez]
AID - S0890-8567(09)61911-0 [pii]
AID - 10.1097/01.chi.0000235082.63156.27 [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 
      10.1097/01.chi.0000235082.63156.27.