Morning and Evening Effects of Guanfacine Extended Release Adjunctive to Psychostimulants in Pediatric ADHD.
To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ).



Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo.



CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate.



Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.
1 Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Timothy E
TE
Wilens
2 University of California, San Francisco, San Francisco, CA, USA.
Keith
K
McBurnett
3 Westex Clinical Investigations, Lubbock, TX, USA.
John
J
Turnbow
4 Children's Specialized Hospital, Toms River, NJ, USA.
Thomas
T
Rugino
5 Shire Pharmaceutical Development Ltd., Basingstoke, UK.
Carla
C
White
6 Drexel University College of Medicine, Philadelphia, PA, USA; formerly of Shire Development, LLC, Wayne, PA, USA.
Sharon
S
Youcha
D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000661:Amphetamine / Q000008:administration & dosage / Q000009:adverse effects; D000704:Analysis of Variance; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016316:Guanfacine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects; D010290:Parents; D012574:Schools; D016896:Treatment Outcome
D058647:Adrenergic alpha-2 Receptor Agonists; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate; D016316:Guanfacine; D000661:Amphetamine
Intuniv; after school; before school; functioning; guanfacine XR