Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
, 45 (7), 817-23

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

Affiliations
Randomized Controlled Trial

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder

Laurence L Greenhill et al. J Am Acad Child Adolesc Psychiatry.

Abstract

Objective: The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD).

Method: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with DSM-IV-defined ADHD. The study was carried out between 2001 and 2003. After a 2-week evaluation phase, patients were randomized to d-MPH-ER or placebo for 7 weeks. Flexible d-MPH-ER dosing (30 mg/day) was permitted for 5 weeks, then patients remained on their optimal dose during the last 2 study weeks. The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version (CADS-T) total subscale score. Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores, CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores, Clinical Global Impressions-Improvement (CGI-I) and CGI-Severity (CGI-S) scale scores, and Child Health Questionnaire Parent Form 50 scores.

Results: d-MPH-ER improved CADS-T total scores significantly compared with placebo (p <.001), and 67.3% of d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3% of placebo patients (p <.001). More patients taking d-MPH-ER (49.1%) than placebo (25.5%) spontaneously reported adverse events suspected as drug related.

Conclusions: Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents.

Similar articles

See all similar articles

Cited by 19 articles

See all "Cited by" articles

Publication types

MeSH terms

Substances

Feedback