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


CONCLUSIONS
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.
Childress
Ann C
AC
Center for Psychiatry and Behavioral Medicine Inc , Las Vegas, Nevada 89128, USA. drann87@aol.com
Spencer
Thomas
T
Lopez
Frank
F
Gerstner
Ortrud
O
Thulasiraman
Anuradha
A
Muniz
Rafael
R
Post
Anke
A
D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D002214:Capsules; D002648:Child; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D064699:Dexmethylphenidate Hydrochloride; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects*; D009422:Nervous System Diseases / Q000139:chemically induced / Q000453:epidemiology; D012871:Skin Diseases / Q000139:chemically induced / Q000453:epidemiology
D002214:Capsules; D003692:Delayed-Action Preparations; D064699:Dexmethylphenidate Hydrochloride; D008774:Methylphenidate