Randomized, double-blind trial of guanfacine extended release in children with
attention-deficit/hyperactivity disorder: morning or evening administration.
Author(s): Newcorn JH(1), Stein MA, Childress AC, Youcha S, White C, Enright G, Rubin J.
Affiliation(s): Author information:
(1)Icahn School of Medicine at Mount Sinai. jeffrey.newcorn@mssm.edu
Publication date & source: 2013, J Am Acad Child Adolesc Psychiatry. , 52(9):921-30
OBJECTIVE: To examine the efficacy and tolerability of guanfacine extended
release (GXR) administered in the morning or evening in children with
attention-deficit/hyperactivity disorder (ADHD).
METHOD: In this multicenter, double-blind, placebo-controlled, dose-optimization
study, children 6 to 12 years of age with ADHD were randomized to receive GXR
(1-4 mg/d) in the morning and placebo in the evening (GXR am), placebo in the
morning and GXR in the evening (GXR pm), or twice-daily placebo. The primary
efficacy measure was the ADHD Rating Scale-IV (ADHD-RS-IV).
RESULTS: A total of 333 child participants received study drug in the following
cohorts: GXR am (n = 107), GXR pm (n = 114), or placebo (n = 112). Mean (standard
deviation) changes from baseline to week 8 (visit 10 or last observation carried
forward) in ADHD-RS-IV total scores were significant for both GXR treatment
groups combined (GXR all-active: -20.0 [12.97]) and separately (GXR am: -19.8
[12.95]; GXR pm: -20.1 [13.04]) compared with placebo (-11.0 [12.93]; p < .001
for all). Most spontaneously-elicited treatment-emergent adverse events were mild
or moderate in severity; the most common was somnolence (GXR all-active: 44.3%;
GXR am: 46.7%; GXR pm: 42.1%; placebo: 12.5%).
CONCLUSIONS: GXR administered either in the morning or evening was associated
with significant and clinically meaningful improvements in ADHD symptoms. The
levels of response and tolerability observed with GXR were similar regardless of
time of dosing (morning versus evening), indicating that once-daily GXR
monotherapy is effective whether administered in the morning or evening. Clinical
trial registration information-Tolerability and Efficacy of AM and PM Once Daily
Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With
Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study.
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