A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of osmotic-controlled release oral delivery system methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in Japan.
OBJECTIVE
To evaluate the safety and efficacy of osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) HCl in adults with attention-deficit/hyperactivity disorder (ADHD).


METHODS
In this study, 284 adults with ADHD were randomized to OROS MPH or placebo. During the 4-week titration period, patients were titrated from a starting dose of 18 mg once daily to an individually-optimized dose of up to 72 mg once daily in weekly 18-mg increments. Patients continued on their individualized dose during the 4-week efficacy assessment period. The primary efficacy endpoint was change in DSM-IV Total ADHD Symptoms subscale score of Conners' Adult ADHD Rating Scale-Observer: Screening Version (CAARS-O:SV) from baseline to endpoint.


RESULTS
The mean change in DSM-IV Total ADHD Symptoms subscale score of CAARS-O:SV was significantly larger with OROS MPH compared with placebo (P < 0.0001, ANCOVA). Similar results were observed for the majority of secondary endpoints, including CAARS-O:SV total score and other subscale scores. Although treatment-emergent adverse events were reported more frequently in the OROS MPH group (81.8%) versus the placebo group (53.9%), OROS-MPH showed a well-tolerated safety profile overall.


CONCLUSIONS
OROS MPH in a dose range of 18-72 mg once daily was effective and well-tolerated in adult patients with ADHD.
Clinical Responsible Physician Department, Clinical Science Division , Janssen Pharmaceutical K.K, Tokyo , Japan.
Nagahide
N
Takahashi
Tadaishi
T
Koh
Yushin
Y
Tominaga
Yuki
Y
Saito
Yuji
Y
Kashimoto
Taka
T
Matsumura
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D010919:Placebos; D008774:Methylphenidate
Japan; adult; attention deficit disorder with hyperactivity; methylphenidate; randomized controlled trial