Clonidine Extended-Release Tablets as Add-on Therapy to Psychostimulants in Children and Adolescents With ADHD

Abstract

OBJECTIVE: To assess the efficacy and safety of clonidine hydrochloride extended-release tablets (CLON-XR) combined with stimulants (ie, methylphenidate or amphetamine) for attention-deficit/hyperactivity disorder (ADHD). PATIENTS AND METHODS: In this phase 3, double-blind, placebo-controlled trial, children and adolescents with hyperactive- or combined-subtype ADHD who had an inadequate response to their stable stimulant regimen were randomized to receive CLON-XR or placebo in combination with their baseline stimulant medication. Predefined efficacy measures evaluated change from baseline to week 5. Safety was assessed by spontaneously reported adverse events, vital signs, electrocardiogram recordings, and clinical laboratory values. Improvement from baseline for all efficacy measures was evaluated using analysis of covariance. RESULTS: Of 198 patients randomized, 102 received CLON-XR plus stimulant and 96 received placebo plus stimulant. At week 5, greater improvement from baseline in ADHD Rating Scale IV (ADHD-RS-IV) total score (95% confidence interval: −7.83 to −1.13; P = .009), ADHD-RS-IV hyperactivity and inattention subscale scores (P = .014 and P = .017, respectively), Conners' Parent Rating Scale scores (P < .062), Clinical Global Impression of Severity (P = .021), Clinical Global Impression of Improvement (P = .006), and Parent Global Assessment (P = .001) was observed in the CLON-XR plus stimulant group versus the placebo plus stimulant group. Adverse events and changes in vital signs in the CLON-XR group were generally mild. CONCLUSIONS: The results of this study suggest that CLON-XR in combination with stimulants is useful in reducing ADHD in children and adolescents with partial response to stimulants.

Attention-Deficit/Hyperactivity Disorder in Young Children: Predictors of Diagnostic Stability

“…[32][33][34][35][36][37][38][39][40] The PGA is a 7-point scale ranging from 1 (no impairments) to 7 (needs 24-hour supervision due to severe impairments). For children who were being treated with stimulant medications, parents were asked to complete rating scales describing their child' s behavior on and off medication (eg, before the medication took effect in the morning).…”

Developments and challenges in the diagnosis and treatment of ADHD

“…59 There is good level of evidence provided by meta-analysis of efficacy for atomoxetine. 57,60,61 Extended-release clonidine [62][63][64] and extended-release guanfacine 65,66 are also efficacious options for the treatment of ADHD, alone or in combination with stimulants. Other pharmacologic alternatives evaluated for the treatment of ADHD are modafinil, bupropion, 57 and tricyclic antidepressants, 67 but all of them have showed weaker evidence of efficacy.…”

ADHD and Sleep Problems in Children

“…Clonidine has been helpful in treating sleeping problems in children with ADHD (Plizka, 2007). Trials of long acting clonidine (with and without the use of psychostimulants) have shown that somnolence and/or fatigue are the major sleeprelated adverse effect of treatment (Biederman et al, 2008;Kollins et al, 2011). However, Biederman et.…”