Efficacy and safety of dexmethylphenidate extended-release capsules administered once daily to children with attention-deficit/hyperactivity disorder.

Abstract

OBJECTIVE:

This 5-week, multicenter, double-blind, placebo-controlled, parallel-group investigation is the first fixed-dose study to evaluate efficacy and tolerability of three doses of (10, 20, or 30 mg, once daily [o.d.]) dexmethylphenidate hydrochloride (HCl) extended-release (d-MPH XR; Focalin XR) across multiple settings to treat pediatric attention-deficit/hyperactivity disorder (ADHD).

RESULTS:

ADHD pediatric outpatients (n = 253) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition, criteria were randomized (1:1:1:1) to receive d-MPH XR (10, 20, or 30 mg o.d.) or placebo. Treatment with d-MPH XR significantly (p < 0.001) reduced the mean score (change from baseline) on Conners'-ADHD/DSM-IV Scales (CADS) as assessed by the teacher CADS-T (dose [mean];10 mg [18], 20 mg [16.9], 30 mg [20.7]) and parents, CADS-P (dose [mean];10 mg [15.8]; 20 mg [17.8]; 30 mg [20.5]) compared to placebo (mean CADS-T [5.7]; CADS-P [4.6]). A significant (p < 0.001) proportion of patients in the three d-MPH XR treatment groups showed improvement on the clinician-rated, Clinical Global Impressions-Improvement (CGI-I) scales (10 mg [73.8%]; 20 mg [71.2%]; 30 mg [77.2 %]) and severity ratings (CGI-S) compared to the placebo group (CGI-I, 22.2%). Adverse events were mild to moderate in severity and similar to previous observations for this class of neurostimulants.

CONCLUSION:

All three doses of d-MPH XR (10, 20, or 30 mg o.d), were significantly more effective than placebo in improving ADHD symptoms as confirmed by the teacher, parent and clinician. Additionally, d-MPH XR was well tolerated and demonstrated a consistent safety profile.

• Authors: Ann C Childress, Thomas Spencer, Frank Lopez, Ortrud Gerstner, Anuradha Thulasiraman, Rafael Muniz, Anke Post
• Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol) Vol. 19 Issue 4 Pg. 351-61 (Aug 2009) ISSN: 1557-8992 [Electronic] United States
• PMID: 19702487 (Publication Type: Comparative Study, Controlled Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Capsules
• Delayed-Action Preparations
• Dexmethylphenidate Hydrochloride
• Methylphenidate

Topics

• Attention Deficit Disorder with Hyperactivity (drug therapy, epidemiology, psychology)
• Capsules
• Child
• Delayed-Action Preparations (administration & dosage, adverse effects)
• Dexmethylphenidate Hydrochloride
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Methylphenidate (administration & dosage, adverse effects)
• Nervous System Diseases (chemically induced, epidemiology)
• Skin Diseases (chemically induced, epidemiology)