Remission Rate and Functional Outcomes During a 6-Month Treatment With Osmotic-Release Oral-System Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder

Abstract

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.

Post hoc analyses of response rates to pharmacological treatments in children and adolescents with attention-deficit/hyperactivity disorder

“…Published response rates for OROS-MPH based on this criterion (62% and 66%) are within the range of response rates found in the present analyses (Biederman et al, 2006(Biederman et al, , 2010. Likewise, published values for the proportions of OROS-MPH-treated participants who achieved symptom remission based on SNAP-IV scores (69.3% and 73.2%) are similar to the proportions of participants in the present analyses who achieved an ADHD-RS-IV total score of ⩽18 at the end point (Su et al, 2015). With regard to ATX treatment, the proportion of participants achieving at least a 30% reduction in ADHD-RS-IV total score plus a CGI-I score of 1 or 2 in the present analyses was similar to the 60% who achieved a 25% reduction in ADHD-RS-IV total score in a large retrospective study (1069 patients) that investigated predictive factors for response to ATX (Newcorn et al, 2009).…”

Hallucinations and other psychotic symptoms in response to methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder: a Cochrane systematic review with meta-analysis and trial sequential analysis#

“…Seven of the 17 non-randomized studies were prospective cohort studies ( 60 , 63 , 65 - 67 , 71 , 72 , 74 , 75 ). Three studies were randomized clinical trials without placebo or no-intervention comparators and therefore assessed as prospective cohort studies by only including the methylphenidate groups ( 58 , 59 , 70 ).…”

“…All studies were carried out in outpatient clinics, except one study, which only included hospitalized patients (64). Comorbid schizophrenia, psychotic disorder or psychiatric disorder were exclusion criteria in twothirds of the studies (58)(59)(60)63,65,66,70,71,(73)(74)(75). Five studies only included patients with comorbid disorders, including schizophrenia (64), comorbid conduct disorder or oppositional-defiant disorder (59), severe mood dysregulation (60), sleeping difficulties (58) and velocardiofacial syndrome (49).…”

“…The "grand total" pooled prevalence summarizing data from the non-randomized study category (58,59,(61)(62)(63)(64)(65)(66)(67)(70)(71)(72)(73)(74)(75) and the methylphenidate group in the randomized clinical trials, that is, with placebo as a comparator (46)(47)(48)(49)(50)(51)(52)(53)(54)56,57), was 1.8% (95% confidence interval, 1.2 to 2.8). Note.…”

Conceptual review of measuring functional impairment: findings from the Weiss Functional Impairment Rating Scale

“…One investigation specifically attempted to validate the criteria for ADHD remission against actual functional outcomes, and found that patients who achieved remission via two differing definitions based on an ADHD symptom severity had significantly greater functional improvement at 8 and 24 weeks of follow-up than non-remitters. 10 While these findings are reassuring in demonstrating that treatment of symptoms has downstream impact on functioning and well-being, they also illustrate that optimisation of functional improvement can only be achieved if we measure and identify those areas of impairment that are problematic. Examples might include life skills that require organisation skills training, deficits in self-esteem that indicate the need for psychotherapy, or family conflict that would benefit from parent training or family therapy.…”