A Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine Extended Release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Jan 2, 2008Pediatrics

Guanfacine extended release effects in children and teens with ADHD: a randomized, double-blind, placebo-controlled study

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Abstract

A total of 345 patients participated, with those taking guanfacine extended release showing significant improvements in ADHD symptoms compared to placebo.

Guanfacine extended release resulted in least-squares mean reductions in ADHD Rating Scale IV total scores of -16.18, -16.43, and -18.87 for the 2 mg, 3 mg, and 4 mg groups, respectively.
The placebo group showed a mean reduction of only -8.48 in ADHD symptoms.
Significant improvements were observed in hyperactivity/impulsivity and inattentiveness subscales for all guanfacine groups compared to placebo.
Commonly reported side effects included headache, somnolence, fatigue, upper abdominal pain, and sedation.
Small to modest changes in blood pressure, pulse rate, and electrocardiogram parameters were noted but were not clinically significant.

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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.

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A Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine Extended Release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

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