Cited by 53Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesNeurotransmitter Receptor Influence on Behavior

Psychomotor Functioning and Alertness with Guanfacine Extended Release in Subjects with Attention-Deficit/Hyperactivity Disorder

Kollins, Scott H., López, Frank A., Vince, Bradley D., Turnbow, John M., Farrand, Kimberly, Lyne, Andrew, Wigal, Sharon B., Roth, Thomas·2011·Journal of Child and Adolescent Psychopharmacology

Abstract

Objectives To determine whether treatment with guanfacine extended release (GXR) in subjects with attention-deficit/hyperactivity disorder (ADHD) disrupted psychomotor functioning and alertness, or impacted daytime sleepiness. Method This was a randomized, double-blind, placebo-controlled, multicenter, phase 2, dose-optimization, noninferiority, laboratory classroom study of GXR (1, 2, and 3 mg/day) in 182 subjects aged 6 to 17 years with ADHD. Psychomotor functioning and alertness were assessed through several measures, including the Choice Reaction Time (CRT) test from the Cambridge Neuropsychological Test Automated Battery. Sedative effects were examined via spontaneously reported adverse events of sedation, somnolence, and hypersomnia as well as fatigue and lethargy, and with two validated subject- and observer-rated sleepiness scales. Standard efficacy measures for ADHD also were included. Cardiovascular and laboratory parameters were assessed. Results There were no significant differences between the GXR and placebo groups on measures of psychomotor functioning or alertness from the CRT at endpoint (least-square mean difference: 2.5 [95% confidence interval (CI): -22.9, 28.0], p = 0.8 for CRT; 2.5 [95% CI: -21.5, 26.4], p = 0.84 for correct responses; 15.5 [95% CI: -45.1, 14.1], p = 0.30 for movement time; and -8.2 [95% CI: -54.1, 37.6] p = 0.72 for total time). Most sedative adverse events were mild to moderate, occurred during dose titration, decreased with dose maint…

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Crossref · 10.1089/cap.2010.0064

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  • Most studies found no effects of guanfacine on cognition in people with ADHD.

    “The majority of studies found no effects of guanfacine on cognition; eight weeks of guanfacine compared to placebo did not improve WM performance, response inhibition, MRT, or RTV in 182 children with ADHD (39); likewise, 45 days of guanfacine relative to placebo had no effect on RT, sustained attention, spatial WM, and visual-motor processing in 178 children with ADHD (40).”
  • Guanfacine, while improving ADHD symptoms relative to placebo, may not be an optimal drug to improve specific attention measures.

    “Together, this suggests that guanfacine, while improving ADHD symptoms relative to placebo (39–41, 43, 44), may not be an optimal drug to improve specific attention measures.”
  • The study adds to the majority of previous studies showing either no or negative effects of guanfacine on cognition in children with ADHD.

    “Nevertheless, our study adds to the majority of previous studies showing either no (39–42) or negative effects (43) of guanfacine on cognition in children with ADHD, with only a single very small numbered study in 17 adults with ADHD showing cognitive improvement in interference inhibition (44).”
  • The study's findings extend evidence of no acute or chronic effects of guanfacine on cognitive performance in children and adults with ADHD.

    “They also extend evidence of no acute or chronic effects of guanfacine on cognitive performance in children and adults with ADHD (39–42).”
  • There is evidence that guanfacine decreases arousal in animal models and people with addiction, and decreases physiological parameters related to arousal like blood pressure and pulse in children with ADHD.

    “There is evidence that guanfacine decreases arousal in animal models (82) and people with addiction (83), and decreases physiological parameters that are related to arousal like blood pressure and pulse in children with ADHD (40, 84).”

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Authors
Kollins, S. H., López, F. A., Vince, B. D., Turnbow, J. M., Farrand, K., Lyne, A., Wigal, S. B., & Roth, T.
Affiliations
  • Duke Medical Center (US)
  • Children's Developmental Center
  • Altasciences Clinical Research Vince & Associates (US)
  • Westex Clinical Investigations
  • Takeda (United States) (US)
  • Shire (United Kingdom) (GB)
  • University of California, Irvine (US)
  • Henry Ford Hospital (US)
Corresponding author
Kollins, Scott H.
Venue
Journal of Child and Adolescent Psychopharmacology
Published
2011-04
Volume
21
Issue
2
Pages
111-120
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
OpenAlex
W2017449681
Cited by
53
References
30
Citations by year
2025: 2 · 2024: 3 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 1 · 2018: 3 · 2017: 5 · 2016: 6 · 2015: 5 · 2014: 11 · 2013: 4 · 2012: 2
FWCI
4.18
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Cell Science Research Foundation
  • National Institute on Drug Abuse
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Keywords
guanfacine extended release, attention deficit hyperactivity disorder, alertness, daytime sleepiness, sedation, choice reaction time, cognitive impairment, ADHD symptoms, children and adolescents, dose optimization, non-inferiority, sleepiness, fatigue, cardiovascular safety, adverse events, ADHD Rating Scale-IV, CANTAB
MeSH terms
Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Fatigue, Female, Humans, Disorders of Excessive Somnolence, Male, Placebos, Psychiatric Status Rating Scales, Psychomotor Performance, Guanfacine, Treatment Outcome, Adrenergic alpha-2 Receptor Agonists

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