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Clinical Trial
, 127 (6), e1406-13

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

Affiliations
Clinical Trial

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

Scott H Kollins et al. Pediatrics.

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.

Figures

FIGURE 1
FIGURE 1
Patient disposition during the treatment phase. PBO indicates placebo; STM, stimulant.
FIGURE 2
FIGURE 2
Improvement in ADHD-RS-IV total score from baseline. Improvement was significantly greater in the CLON-XR plus stimulant group versus the placebo plus stimulant group starting at week 2 and continuing through week 7. PBO indicates placebo; STM, stimulant. aP < .05.
FIGURE 3
FIGURE 3
Improvement in ADHD-RS-IV total score from baseline to week 5 in CLON-XR and placebo combined with different classes of stimulants. Improvement in ADHD-RS-IV total score was not statistically significant in patients who received placebo or CLON-XR plus methylphenidate (METH) or amphetamine (AMP). PBO indicates placebo.
FIGURE 4
FIGURE 4
Alteration of stimulant medication dosage during the study. A greater percentage of patients in the CLON-XR plus stimulant group (15%) decreased their dose of stimulant compared with patients in the placebo plus stimulant group (10%). PBO indicates placebo; STM, stimulant.

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