Clonidine extended-release tablets as add-on therapy to psychostimulants in
children and adolescents with ADHD.
Author(s): Kollins SH, Jain R, Brams M, Segal S, Findling RL, Wigal SB, Khayrallah M.
Affiliation(s): Department of Psychiatry, Duke University Medical Center, Durham, North Carolina,
USA. kolli001@mc.duke.edu
Publication date & source: 2011, Pediatrics. , 127(6):e1406-13
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.
|