Effectiveness of methylphenidate in the 10-month continuation phase of the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS).
OBJECTIVE
The aim of this study was to examine immediate-release methylphenidate effectiveness during the 10-month open-label continuation phase of the Preschoolers with Attention-Deficit/Hyperactivity Disorder (ADHD) Treatment Study (PATS).


METHODS
One hundred and forty preschoolers with ADHD, who had improved with acute immediate-release methylphenidate (IR-MPH) treatment, entered a 10-month, open-label medication maintenance at six sites. Assessments included the Clinical Global Impression-Severity (CGI-S), CGI-Improvement (CGI-I), Children's Global Assessment Scale (C-GAS), Swanson, Nolan, and Pelham Questionnaire (SNAP), Scale Strengths and Weaknesses of ADHD-Symptoms and Normal Behaviors (SWAN), Social Competence Scale, Social Skills Rating System (SSRS), and Parenting Stress Index-Short Form (PSI-SF).


RESULTS
For the 95 children who completed the 10-month treatment, improvement occurred on the CGI-S (p = 0.02), CGI-I (p < 0.01), C-GAS (p = 0.001), and SSRS (p = 0.01). SNAP and SWAN scores remained stable. Forty five children discontinued: 7 for adverse effects, 7 for behavior worsening, 7 for switching to long-acting stimulants, 3 for inadequate benefit, and 21 for other reasons. The mean MPH dose increased from 14.04 mg/day +/- SD 7.57 (0.71 +/- 0.38 mg/kg per day) at month 1 to 19.98 mg/day +/- 9.56 (0.92 +/- 0.40 mg/kg per day) at month 10.


CONCLUSIONS
With careful monitoring and gradual medication dose increase, most preschoolers with ADHD maintained improvement during long-term IR-MPH treatment. There was substantial variability in effective and tolerated dosing.
Vitiello
Benedetto
B
Child and Adolescent Treatment and Preventive Intervention Research Branch, National Institute of Mental Health, 6001 Executive Boulevard, Bethesda, MD 20892, USA. bvitiell@nail.nih.gov
Abikoff
Howard B
HB
Chuang
Shirley Z
SZ
Kollins
Scott H
SH
McCracken
James T
JT
Riddle
Mark A
MA
Swanson
James M
JM
Wigal
Tim
T
McGough
James J
JJ
Ghuman
Jaswinder K
JK
Wigal
Sharon B
SB
Skrobala
Anne M
AM
Davies
Mark
M
Posner
Kelly
K
Cunningham
Charles
C
Greenhill
Laurence L
LL
D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D010290:Parents / Q000523:psychology; D010352:Patient Dropouts; D011569:Psychiatric Status Rating Scales; D012959:Socioeconomic Factors; D013315:Stress, Psychological / Q000523:psychology
D000697:Central Nervous System Stimulants; D008774:Methylphenidate