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Event Related Potentials (ERPs) and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
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Clonidine extended-release: in attention-deficit hyperactivity disorder.

Jamie D Croxtall1

  • 1Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz

Paediatric Drugs
|September 6, 2011
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Extended-release clonidine effectively treats attention-deficit hyperactivity disorder (ADHD) in children and adolescents. This ADHD medication demonstrated significant symptom improvement in clinical trials, both as a standalone treatment and with stimulant regimens.

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Area of Science:

  • Pharmacology
  • Neuroscience
  • Pediatric Medicine

Background:

  • Clonidine, an alpha-2 adrenergic agonist, is an FDA-approved extended-release (XR) tablet for treating attention-deficit hyperactivity disorder (ADHD) in pediatric patients aged 6-17 years.
  • Existing ADHD treatments often require combination therapy for optimal symptom management.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of extended-release clonidine (clonidine XR) as monotherapy and adjunctive therapy for ADHD in children and adolescents.
  • To determine the onset of action for clonidine XR in improving ADHD symptoms.

Main Methods:

  • Two randomized, double-blind, multicenter, phase III clinical trials of 8 weeks' duration were conducted.
  • Participants received either clonidine XR monotherapy (0.2 and 0.4 mg/day) or clonidine XR (flexible dose 0.1-0.4 mg/day) as adjunctive therapy to stimulants, compared against placebo.
  • The primary endpoint was the change in ADHD Rating Scale IV (ADHD-RS-IV) total scores at week 5.

Main Results:

  • Clonidine XR monotherapy (0.2 and 0.4 mg/day) showed significantly greater reductions in ADHD-RS-IV scores at week 5 compared to placebo.
  • Adjunctive clonidine XR (0.1-0.4 mg/day) also demonstrated significantly greater reductions in ADHD-RS-IV scores at week 5 versus placebo.
  • Symptomatic improvement was observed as early as week 2, with significantly greater reductions in ADHD-RS-IV scores for clonidine XR recipients from week 2 onwards.

Conclusions:

  • Extended-release clonidine is an effective treatment for ADHD symptoms in children and adolescents, both as monotherapy and when added to stimulant regimens.
  • Clonidine XR offers a rapid onset of action, providing symptomatic relief within two weeks.
  • The medication was generally well-tolerated in the studied pediatric population.