A Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine Extended Release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
- 1 January 2008
- journal article
- research article
- Published by American Academy of Pediatrics (AAP) in Pediatrics
- Vol. 121 (1), e73-e84
- https://doi.org/10.1542/peds.2006-3695
Abstract
OBJECTIVE. With this study we assessed the efficacy and safety of an extended-release formulation of guanfacine compared with placebo for the treatment of children and adolescents with attention-deficit/hyperactivity disorder. METHODS. In this multicenter, double-blind, placebo-controlled, fixed-dosage escalation study, patients aged 6 to 17 years were randomly assigned to 1 of 3 treatment groups of guanfacine extended release (2, 3, or 4 mg/day) or placebo for 8 weeks. The primary outcome measurement was the Attention-Deficit/Hyperactivity Disorder Rating Scale IV total score. Secondary measurements included Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale–Revised: Short Form, and Conners' Teacher Rating Scale–Revised: Short Form. RESULTS. A total of 345 patients were randomly assigned to placebo (n = 86) or guanfacine extended release 2 mg (n = 87), 3 mg (n = 86), or 4 mg (n = 86) treatment groups. Least-squares mean changes from baseline to the end point in Attention-Deficit/Hyperactivity Disorder Rating Scale IV total scores were significant in all groups of children taking guanfacine extended release: −16.18 in the 2-mg group, −16.43 in the 3-mg group, and −18.87 in the 4-mg group, compared with −8.48 in the placebo group. All groups of children taking guanfacine extended release showed significant improvement on hyperactivity/impulsivity and inattentiveness subscales of the Attention-Deficit/Hyperactivity Disorder Rating Scale IV, Clinical Global Impression of Improvement, Parent's Global Assessment, Conners' Parent Rating Scale–Revised: Short Form, and Conners' Teacher Rating Scale–Revised: Short Form assessments compared with placebo. The most commonly reported treatment-emergent adverse events were headache, somnolence, fatigue, upper abdominal pain, and sedation. Small to modest changes in blood pressure, pulse rate, and electrocardiogram parameters were observed but were not clinically meaningful. CONCLUSIONS. Guanfacine extended release met the primary and secondary efficacy end points. It was well tolerated and effective compared with placebo.Keywords
This publication has 34 references indexed in Scilit:
- Once-Daily Atomoxetine Treatment for Children With Attention-Deficit/Hyperactivity Disorder, Including an Assessment of Evening and Morning Behavior: A Double-Blind, Placebo-Controlled TrialPediatrics, 2004
- Once-Daily Atomoxetine Treatment for Children and Adolescents With Attention Deficit Hyperactivity Disorder: A Randomized, Placebo-Controlled StudyAmerican Journal of Psychiatry, 2002
- Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Randomized, Placebo-Controlled, Dose-Response StudyPublished by American Academy of Pediatrics (AAP) ,2001
- A Placebo-Controlled Study of Guanfacine in the Treatment of Children With Tic Disorders and Attention Deficit Hyperactivity DisorderAmerican Journal of Psychiatry, 2001
- A Pilot Study of Methyiphenidate, Clonidine, or the Combination in ADHD Comorbid with Aggressive Oppositional Defiant or Conduct DisorderClinical Pediatrics, 2000
- Guanfacine for Treatment of Attention-Deficit Hyperactivity Disorder in BoysJournal of Child and Adolescent Psychopharmacology, 1995
- Guanfacine as an alpha-2-agonist inducer of growth hormone secretion—a comparison with clonidinePsychoneuroendocrinology, 1993
- Clonidine in Child and Adolescent PsychiatryJournal of Child and Adolescent Psychopharmacology, 1990
- GuanfacineDrugs, 1986
- Stimulant medications precipitate Tourette's syndromePublished by American Medical Association (AMA) ,1982