Cited by 32Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesBehavioral and Psychological Studies

Guanfacine extended release adjunctive to a psychostimulant in the treatment of comorbid oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder

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Findling, Robert L., McBurnett, Keith, White, Carla, Youcha, Sharon·2014·Journal of Child and Adolescent Psychopharmacology

Abstract

OBJECTIVE: The purpose of this study was to assess the effect of guanfacine extended release (GXR) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: A multicenter, double-blind, placebo-controlled dose-optimization study of GXR (1-4 mg/d) or placebo administered morning (a.m.) or evening (p.m.) adjunctive to psychostimulant was conducted in subjects ages 6-17 with suboptimal response to psychostimulant alone. Suboptimal response was defined as treatment with a stable dose of psychostimulant for ≥4 weeks with ADHD Rating Scale IV total score ≥24 and Clinical Global Impressions-Severity of Illness score ≥3, as well as investigator opinion. Primary efficacy and safety results have been reported previously. Secondary efficacy measures included the oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L); these are reported herein. RESULTS: Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R:L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant, both in the overall study population (placebo-adjusted least squares [LS] mean change from baseline to the final on-treatment assessment: GXR a.m.+psychostimulant, -2.4, p=0.001; GXR p.m.+psychostimulant, -2.2, p=0.003) as well as in the subgroup of subjects with significant baseline oppositional symptoms (GXR a.m.+psychostimulant, -3.6, p=0.001; GXR p.m.+psychostimulant, -2.7, p=0.013). Treatment-emergent adverse events were reported by 77.3%, 76.3%, and 63.4% of subjects in the GXR a.m., GXR p.m., and placebo groups, respectively, in the overall study population. CONCLUSIONS: GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone.

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Authors
Findling, R. L., McBurnett, K., White, C., & Youcha, S.
Affiliations
  • Kennedy Krieger Institute (US)
  • University of California, San Francisco (US)
  • Shire (United Kingdom) (GB)
  • Drexel University (US)
Corresponding author
Findling, Robert L.
Venue
Journal of Child and Adolescent Psychopharmacology
Published
2014-06
Volume
24
Issue
5
Pages
245-252
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
OpenAlex
W2001542004
Cited by
32
References
29
Citations by year
2025: 2 · 2024: 1 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 5 · 2017: 3 · 2016: 4 · 2015: 7
FWCI
3.56
Type
journal article
Language
en
Open access
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion)
  • PubMed Central (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
  • Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
Keywords
guanfacine extended release, attention deficit hyperactivity disorder, psychostimulants, adjunctive therapy, children and adolescents, dose optimization, treatment-emergent adverse events
MeSH terms
Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Psychiatric Status Rating Scales, Severity of Illness Index, Guanfacine, Attention Deficit and Disruptive Behavior Disorders, Adrenergic alpha-2 Receptor Agonists

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