A prospective open trial of guanfacine in children with pervasive developmental disorders.
OBJECTIVE
A common complaint for children with pervasive developmental disorder (PDD) is hyperactivity. The purpose of this pilot study was to gather preliminary information on the efficacy of guanfacine in children with PDD and hyperactivity.


METHODS
Children with PDD accompanied by hyperactivity entered the open-label trial if there was a recent history of failed treatment with methylphenidate or the child did not improve on methylphenidate in a multisite, placebo-controlled trial.


RESULTS
Children (23 boys and 2 girls) with a mean age of 9.03 (+/-3.14) years entered the open-label trial. After 8 weeks of treatment, the parent-rated Hyperactivity subscale of the Aberrant Behavior Checklist (ABC) went from a mean of 31.3 (+/-8.89) at baseline to 18.9 (+/-10.37) (effect size = 1.4; p < 0.001). The teacher-rated Hyperactivity subscale decreased from a mean of 29.9 (+/-9.12) at baseline to 22.3 (+/-9.44) (effect size = 0.83; p < 0.01). Twelve children (48%) were rated as Much Improved or Very Much Improved on the Clinical Global Impressions- Improvement. Doses ranged from 1.0 to 3.0 mg/day in two or three divided doses. Common adverse effects included irritability, sedation, sleep disturbance (insomnia or midsleep awakening), and constipation. Irritability led to discontinuation in 3 subjects. There were no significant changes in pulse, blood pressure, or electrocardiogram.


CONCLUSIONS
Guanfacine may be useful for the treatment of hyperactivity in children with PDD. Placebo-controlled studies are needed to guide clinical practice.
Scahill
Lawrence
L
Yale Child Study Center, P.O. Box 207900, New Haven, CT 06520, USA. lawrence.scahill@yale.edu
Aman
Michael G
MG
McDougle
Christopher J
CJ
McCracken
James T
JT
Tierney
Elaine
E
Dziura
James
J
Arnold
L Eugene
LE
Posey
David
D
Young
Christopher
C
Shah
Bhavik
B
Ghuman
Jaswinder
J
Ritz
Louise
L
Vitiello
Benedetto
B
D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000175:diagnosis / Q000188:drug therapy*; D002675:Child, Preschool; D005260:Female; D016316:Guanfacine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use; D010552:Personality Assessment; D010865:Pilot Projects; D011446:Prospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D016316:Guanfacine