To explore changes in daily functioning (C-GAS) and quality of life (ILC) in children and adolescents with ADHD OROS®-MPH and their parents.

Full analysis. Open label non-interventional trial in children & adolescents with ADHD (ICD-10 criteria) treated with flexible dose OROS MPH for 3 months (42603-ATT-4001). Effectiveness parameter were C-GAS, ILC adolescents and parents and IOWA Conners' parent rating scale at baseline and endpoint.

598 patients with ADHD (ICD-10 criteria; Ø age 10.4 years ± 2.6; 84.8% male) were documented. 81.6% completed the observation. Mean OROS MPH dose at last observation was 33.5 mg/day (SD ± 13.3). Patients improved on C-GAS from 58.9±14.7 to 71.2±15.1 (p<0.001). IOWA Connors Symptoms decreased from 29.0 ± 10.5 to 18.5 ± 10.6 (p<0.0001). ILC improved from 18.8 ± 4.0 to 20.8±3.8 in children and adolescents (p<0.0001) and from 17.2±3.9 to 19.7±3.9 in parents (p<0.001). At endpoint, 76.8% of patients showed at least minimal improvement on CGI-C. Adverse events were reported in 28.8% of patients. AEs listed in ≥2% of patients were insomnia (7.7%), anorexia (3.9%), ineffectiveness (2.8%), headache (2.3%), nervousness (2.2%) and involuntary muscle contractions (2.2%). There were no significant changes in blood pressure or pulse.

Treatment with OROS®-MPH was associated with a clinically relevant improvement in daily functioning in patients with ADHD and Qol improved significantly in patients and their parents. Treatment with OROS®-MPH was well tolerated.

To explore changes in daily functioning (C-GAS) and quality of life (ILC) in adolescents (12-18 years) with ADHD treated with OROS®-MPH and their parents.

Post hoc analysis. Open label non-interventional trial in adolescents (ADHD; ICD-10 criteria) treated with flexible dose OROS-MPH for 3 months (42603-ATT-4001). Effectiveness parameter were IOWA Conners' parent rating scale, C-GAS, ILC adolescents and parents at baseline and endpoint, physician's and parents' rating of treatment.

129 out of 598 patients were adolescents (Ø age 14.2 years; 84.5% male) and 88.4% completed the study. Treatment was discontinued due to adverse events (3.9%), insufficient effectiveness (4.6%), lost to follow up (3.1%). Mean dose of OROS MPH increased from 34.6 mg/day ± 13.4 at baseline to 39.2 mg/day ± 13.4 at endpoint. C-GAS improved from 60.2 ± 14.0 to 72 ± 14.4 (p<0.001). Mean sum score on ILC-adolescents improved from 18.7 ± 3.6 to 20.6 ± 3.7 (p<0.001) and ILC-parents increased from 16.7 ± 3.9 to 19.6 ± 3.8 (p<0.001). Effectivity and tolerability was rated as at least good by >80% of physicians. 80.6% of parents were at least satisfied with therapy. 46 treatment - emergent adverse events were reported in 30 patients. AEs listed overall in ≥2% of patients were insomnia (3.9%), infection (2.3%), headache (2.3%), and nervousness (2.3%).

Transitioning onto OROS®-MPH in adolescents was associated with a clinically relevant improvement of Qol and daily functioning. Treatment with OROS MPH was well tolerated.

To explore changes in quality of life (ILC) in adolescents with attention-deficit/hyperactivity-disorder (ADHD) transitioning from Atomoxetine (ATX) or ER MPH (Medikinet retard) onto OROS MPH.

Post hoc analysis. 12 week, open label non-interventional trial in adolescents (ADHD; ICD-10 criteria) transitioning from ER MPH or Atomoxetine onto flexible dose of OROS MPHs. Effectiveness parameter were changes in IOWA Conners' parent rating scale, C-GAS, ILC adolescents and parents and questions focusing on afternoon activities.

57 adolescents were analyzed (median age 14 years, 84.2% male). Insufficient efficacy (77.2%), adverse events (3.5%) or a combination of both (19.3%) led to transition to OROS MPH. Mean dose of ER MPH prior was 34,3mg±19,3 and mean dose of atomoxetine was 53,2mg±17,9. Eight patients terminated the study prematurely. Median dose of OROS MPH at endpoint was 54mg/day. "Playing with other children", "doing household chores", "doing homework", "going to bed in the evening", and "ability to visit or receive visitors" improved (all p<0.001) as well as C-GAS (p<0.00001), Conner's parent rating scale, ILC parents and adolescent's (all p<0.001).

Adverse events (AE) with under OROS MPH treatment were reported in 45.6% of patients. AE ≥5% were involuntary muscle contractions not further specified (5.3%), insomnia (5.3%), and ineffective medication (5.3%).

Transitioning from ER MPH or ATX to OROS MPH in adolescents with ADHD was associated with an improvement in quality of life in adolescents and their parents and in daily functioning. Improved symptom control during late afternoon and early evening activities was apparent.

Data on the relationship between core symptoms and daily functioning in adults with attention deficit hyperactivity disorder (ADHD) are limited. Daily functioning was assessed as part of an open-label extension, and associations with symptom scores were evaluated.

After a 5-week double-blind study with adults with ADHD receiving osmotic-controlled release oral delivery system (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo, participants were eligible for a 7-week open-label extension in which all patients received OROS MPH. Data for the Conners' Adult ADHD Rating Scale – Observer: Screening Version (CAARS-O:SV) (primary endpoint) have been presented previously. Secondary endpoints included the observer self-reported short version of the CAARS (CAARS-S:S) and the Clinical Global Impressions – Severity Scale (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) respectively. In post-hoc analyses, changes in CAARS-O:SV were evaluated in subgroups. Relationships between symptom and functional outcomes were evaluated in a multivariate regression analysis.

A total of 370 patients entered the open-label extension. Significant improvements from baseline in CAARS-O:SV were similar regardless of sex, ADHD subtype, prior treatment or psychiatric co-morbidity. Significant improvements from double-blind baseline were also seen for the CAARS-S:S, CGI-S, SDS and Q-LES-Q. Improvements in the CAARS-O:SV Hyperactivity/Impulsivity subscale were associated with improvements in SDS total and subscale scores, and in the Q-LES-Q score at open-label endpoint. Improvements in CAARS-O:SV Inattention subscale and CGI-S scores were not significantly associated with functional changes.

Improvements in ADHD symptoms relating to hyperactivity and impulsivity in adults receiving OROS MPH are associated with improvements in daily functioning and quality of life.