Cited by 142Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Clonidine Extended-Release Tablets for Pediatric Patients With Attention-Deficit/Hyperactivity Disorder

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Jain, Rakesh, Segal, Scott, Kollins, Scott H., Khayrallah, Moise·2011·Journal of the American Academy of Child & Adolescent Psychiatry

Abstract

Objective This study examined the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).Method This 8-week, placebo-controlled, fixed-dose trial, including 3 weeks of dose escalation, of patients 6 to 17 years old with ADHD evaluated the efficacy and safety of CLON-XR 0.2 mg/day or CLON-XR 0.4 mg/day versus placebo in three separate treatment arms. Primary endpoint was mean change in ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to week 5 versus placebo using a last observation carried forward method. Secondary endpoints were improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Severity, Clinical Global Impression of Improvement, and Parent Global Assessment from baseline to week 5.Results Patients (N = 236) were randomized to receive placebo (n = 78), CLON-XR 0.2 mg/day (n = 78), or CLON-XR 0.4 mg/day (n = 80). Improvement from baseline in ADHD-RS-IV total score was significantly greater in both CLON-XR groups versus placebo at week 5. A significant improvement in ADHD-RS-IV total score occurred between groups as soon as week 2 and was maintained throughout the treatment period. In addition, improvement in ADHD-RS-IV inattention and hyperactivity/impulsivity subscales, Conners Parent Rating Scale-Revised: Long Form, Clinical Global Impression of Improvement, Clinical Global Impression of Severity, and Parent Global Assessment, occurred in both treatment groups versus placebo. The most common treatment-emergent adverse event was mild-to-moderate somnolence. Changes on electrocardiogram were minor and reflected the known pharmacology of clonidine.Conclusions Clonidine hydrochloride extended-release tablets were generally well tolerated by patients in the study and significantly improved ADHD symptoms in this pediatric population.

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Crossref · 10.1016/j.jaac.2010.11.005

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  • Non-stimulants approved for ADHD include the selective noradrenaline reuptake inhibitor atomoxetine and long-acting formulations of two α2-adrenergic agonist drugs - clonidine and guanfacine.

    “These include the selective noradrenaline re uptake inhibitor atomoxetine 164 and long-acting formulations of two α2-adrenergic agonist drugs - clonidine 165 and guanfacine 166 .”

    From Attention-deficit/hyperactivity disorder (2015) · cites this paper as [165]

    The Abstract (page unavailable) identifies clonidine as an α2-adrenergic agonist, describes its extended-release formulation, and reports a pediatric ADHD trial. The cited paper therefore supports the clonidine portion of the sentence, but the passages do not establish that the formulation was approved for ADHD. (LLM, conf=0.82)

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  • Atomoxetine and α2-adrenergic agonists are effective in the management of ADHD.

    “These drugs are effective in the management of ADHD”

    From Attention-deficit/hyperactivity disorder (2015) · cites this paper as [165]

  • The sedative effects of α2-adrenergic agonists limit their use in some patients.

    “the sedative effects of α2-adrenergic agonists limit their use in somepatients 165,167 .”

    From Attention-deficit/hyperactivity disorder (2015) · cites this paper as [165]

  • Atomoxetine, extended-release guanfacine, and extended-release clonidine have demonstrated efficacy in reducing core symptoms among school-aged children and adolescents.

    “Among nonstimulant medications, 1 selective norepinephrine reuptake inhibitor, atomoxetine,99,100 and 2 selective α-2 adrenergic agonists, extended-release guanfacine101,102 and extended-release clonidine,103 have also demonstrated efficacy in reducing core symptoms among school-aged children and adolescents”

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Research works printed but not linked: 1

  1. [20]20. Agarwal V, Sitholey P, Kumar S, Prasad M. Double-blind, place- bo-controlled trial of clonidine in hyperactive children with mental retardation. Ment Retard. 2001;39:259-267.

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Authors
Jain, R., Segal, S., Kollins, S. H., & Khayrallah, M.
Affiliations
  • Texas Tech University (US)
  • Duke Medical Center (US)
Corresponding author
Jain, Rakesh
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2011-02
Volume
50
Issue
2
Pages
171-179
ISSN
0890-8567 (ISSN-L)
OpenAlex
W1999789853
Cited by
142
References
35
Citations by year
2026: 7 · 2025: 2 · 2024: 9 · 2023: 8 · 2022: 6 · 2021: 5 · 2020: 9 · 2019: 9 · 2018: 7 · 2017: 5 · 2016: 13 · 2015: 8 · 2014: 17 · 2013: 11 · 2012: 13
FWCI
11.80
Type
journal article
Language
en
Open access
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 › Pharmacology › Pharmacology and Obesity Treatment
Keywords
clonidine, sustained-release tablets, attention deficit hyperactivity disorder, children with ADHD, ADHD symptoms, inattention, hyperactivity/impulsivity, sleepiness, drug safety, dose escalation, ADHD Rating Scale-IV
MeSH terms
Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Clonidine, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Adrenergic alpha-2 Receptor Agonists, Drug-Related Side Effects and Adverse Reactions

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