Remission Rate and Functional Outcomes During a 6-Month Treatment With Osmotic-Release Oral-System Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder.
Many definitions have been used to evaluate remission in patients with attention-deficit/hyperactivity disorder (ADHD) in different studies resulting with varied remission rates. This open-label, multicenter study investigated the remission rate in Chinese children (n = 239; aged 6-16 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), treated with osmotic-release oral-system methylphenidate at doses of 18, 36, and 54 mg, once daily. Two definitions of remission were used: (1) (primary end point): average scores of SNAP-IV (Swanson, Nolan, and Pelham, Fourth Edition) items of 1 or less (0-3 rating scale for each item) according to the subtype of ADHD (inattentive [1-9], hyperactive-impulsive [10-18], and combined type [1-18]), and (2) total score of SNAP-IV items 1 to 18 of 18 or less, at week 8. The study consisted of screening/baseline, titration/open-label treatment (8 weeks), and extended observation (up to 24 weeks) phases. Secondary efficacy assessments were Clinical Global Impression-Improvement (clinical efficacy), Behavior Rating Inventory of Executive Function Scale (BRIEF; executive function behaviors), and Weiss Functional Impairment Rating Scale (social function). Validity of remission was assessed by comparing the function measures (BRIEF and Weiss's) between patients who achieved remission and those who did not. At week 8, 69.3% (151/218) of patients achieved remission by definition 1, and 73.2% (161/220) by definition 2. At weeks 8 and 24, the remission group had significantly lower BRIEF, Weiss's, and Clinical Global Impression-Improvement scores (P < 0.001 for all) compared with the nonremission group. Overall, treatment with osmotic-release oral-system methylphenidate was well tolerated, with increased remission rates in children with ADHD.
From the *Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing; †Jilin University First Hospital, Changchun, Jilin Province; ‡Nanjing Brain Hospital, Nanjing Medical University, Nanjing, Jiangsu Province; §Beijing Children's Hospital, Capital Medical University, Beijing; ∥Shanghai Changzheng Hospital, Shanghai; ¶Soochow University Affiliated Children's Hospital, Suzhou; and #Nanjing Children's Hospital, Nanjing Medical University, Nanjing, Jiangsu Province; and **Janssen Research and Development Department, Xi'an Janssen Pharmaceutical Ltd, Beijing, China.
Yi
Y
Su
Haibo
H
Li
Yixin
Y
Chen
Fang
F
Fang
Tong
T
Xu
Haiping
H
Lu
Ling
L
Xie
Jianmin
J
Zhuo
Jiazhi
J
Qu
Li
L
Yang
Yufeng
Y
Wang
D000284:Administration, Oral; D000293:Adolescent; D044466:Asian People; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002681:China; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009995:Osmosis; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012074:Remission Induction; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate