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Cited by 391Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesSchizophrenia research and treatment

Guanfacine Extended Release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial

Sallee, Floyd R., Mcgough, James, Wigal, Tim, Donahue, Jessica, Lyne, Andrew, Biederman, Joseph·2009·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1097/chi.0b013e318191769e
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Abstract

Objective This study compared the efficacy of guanfacine extended release (GXR), a selective alpha(2A)-adrenoceptor agonist, with placebo in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).Method This double-blind, 9-week, dose-ranging, parallel-design, multicenter trial randomized 6- to 17-year-olds with ADHD to once-daily oral GXR in 1-, 2-, 3-, and 4-mg doses or placebo. Primary outcome was change in total ADHD Rating Scale-IV score from baseline to endpoint. Secondary outcomes included changes in scores of hyperactive/impulsive and inattentive subscales; clinician and parent ratings; duration of clinical effect; and safety measures.Results Statistically significant reductions in ADHD Rating Scale-IV scores were observed from baseline to endpoint at all doses of GXR, with effect sizes ranging from 0.43 to 0.62. In subjects receiving GXR, mean heart rate and systolic and diastolic blood pressure decreased as the dose of GXR increased and then returned toward baseline during the dose-maintenance and dose-tapering phases of the trial. Most frequent treatment-emergent adverse events (> or = 5%) were somnolence, headache, fatigue, sedation, dizziness, irritability, upper abdominal pain, and nausea. Somnolence, sedation, and fatigue adverse events emerged within the first 2 weeks of dosing and generally resolved by study end.Conclusions : Guanfacine extended-release was effective in reducing symptoms of ADHD. Adverse events were mild to moderate, did not interfere with improvements in attention, and rarely led to discontinuation.

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Crossref · 10.1097/chi.0b013e318191769e

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34 of 34 references verified0 citation errors · 0 not checkable

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  • With the exception of one pemoline study and adolescent subgroups in two guanfacine studies, all studies in adolescents with ADHD without SUD reported significant improvements in ADHD symptoms in active medication compared with placebo, with effect sizes of d = 0.53-1.33 for MPH, d = 0.80-1.23 for LDX, d = 0.80 for MAS-XR, d = 2.05 for pemoline, d = 0.99 for atomoxetine, and d = 0.52 for guanfacne

    “With the exception of one pemoline study [33] and the adolescent subgroups in two guanfacine studies [45,46], all studies reported significant improvements in ADHD symptoms in the active medication compared with the placebo groups, with moderate to large effect sizes of Cohen’s d = 0.53–1.33 for MPH, d = 0.80–1.23 for LDX, d = 0.80 for MAS-XR, d = 2.05 for pemoline, d = 0.99 for atomoxetine, and d”

    From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [46]

  • Double-blind placebo-controlled studies have demonstrated that guanfacine is effective in treating ADHD symptoms.

    “double-blind placebo-controlled studies have demonstrated that guanfacine is effective in treating ADHD symptoms”

    From Catecholamine influences on prefrontal cortical function: Relevance to treatment of attention deficit/hyperactivity disorder and related disorders (2011) · cites this paper as Sallee et al., 2009

  • In two short-term, placebo-controlled, double-blind pivotal trials, extended-release guanfacine (Intuniv) as monotherapy reduced symptoms of ADHD, as measured by clinician-rated ADHD-RS-IV total score and the hyperactivity/impulsivity and inattentiveness subscale scores.

    “In 2 short-term, placebo-controlled, double-blind pivotal trials, an extended-release formulation of guanfacine (Intuniv™, Shire US Inc.) has shown efficacy as monotherapy for reducing symptoms of ADHD based on clinician-rated ADHD Rating Scale IV (ADHD-RS-IV) total score as well as the hyperactivity/impulsivity and inattentiveness subscale scores (Biederman et al., 2008; Sallee et al., 2009).”

    From Catecholamine influences on prefrontal cortical function: Relevance to treatment of attention deficit/hyperactivity disorder and related disorders (2011) · cites this paper as Sallee et al., 2009

  • Once-daily extended-release guanfacine has proven effective in both short-term and long-term studies.

    “Recently, once-daily extended-release guanfacine has proven effective in both short-term [90,91] and long-term studies [92,93].”

    From Advances in understanding and treating ADHD (2011) · cites this paper as [90]

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Authors
Sallee, F. R., Mcgough, J., Wigal, T., Donahue, J., Lyne, A., & Biederman, J.
Affiliations
University of California, Los Angeles (US)
Corresponding author
Sallee, Floyd R.
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2009-02
Volume
48
Issue
2
Pages
155-165
ISSN
0890-8567 (ISSN-L)
DOI
10.1097/chi.0b013e318191769e
OpenAlex
W2022741651
Cited by
391
References
34
Citations by year
2026: 8 · 2025: 11 · 2024: 12 · 2023: 6 · 2022: 7 · 2021: 7 · 2020: 166 · 2019: 2 · 2018: 10 · 2017: 9 · 2016: 13 · 2015: 12 · 2014: 27 · 2013: 24 · 2012: 28
FWCI
15.82
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
guanfacine extended release, attention deficit hyperactivity disorder, children and adolescents, ADHD Rating Scale-IV, hyperactivity/impulsivity, inattention, dose-ranging, blood pressure, heart rate, sleepiness, sedation, adverse events
MeSH terms
Adolescent, Adrenergic alpha-Agonists, Attention Deficit Disorder with Hyperactivity, Blood Pressure, Child, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Heart Rate, Humans, Male, Placebos, Psychiatric Status Rating Scales, Guanfacine, Drug Delivery Systems, Treatment Outcome

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