adherence to stimulant treatment in attention-deficit hyperactivity disorder (adhd) patients (asta)

Conditions: ADHD

Summary: this study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the medication event monitoring system (mems). study design: * prospective * multi-centric * open-label * randomized * active-controlled trial

the study is designed as a prospective, multi-centric, open-label, randomized, active-controlled trial. adhd-children and adolescents of both sexes, 6-17 of age, effectively treated with stimulants are recruited in two centres. over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. in the subsequent controlled clinical trial 50% of the participants are randomized to extended release (er) methylphenidate (medikinet retard®) applied with breakfast, 50% are randomized to immediate release (ir) methylphenidate (medikinet®) in the morning and 3-4 h later (clinical trial). to optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded. according to the power calculation 106 patients will be randomized. the total duration of the study is 18 months. starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. medical care is provided in the routine program of both study centres. to record the adherence, medication events are counted by medication event monitoring system (mems).

Eligibility criteria:
inclusion criteria: * written informed consent (separately for children aged 6-11 years and 12-17 years) * children and adolescents of both sexes aged 6 - 17 years * confirmed diagnosis of adhd by semi structured-clinical interview k-sads * adhdrs-iv-parent version (18-item-scale) raw score ≥ 1,5 sd above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months) * effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in adhd-rs under medication, compared to retrospective adhd-rs without medication within the past 6 months. * acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by medice®. * sufficient knowledge of the german language * adequate contraception in case of sexual activity exclusion criteria: * contraindications against methylphenidate * previous stable methylphenidate intake more than twice daily * all severe psychiatric disorders except oppositional defiant disorder (odd) or conduct disorder. in order to reflect the usual co-morbid spectrum of adhd, mild or moderate anxiety or depressive disorders are accepted in the study. * all severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders) * pathological results for vital signs, blood pressure and pulse * reported pathological results for ecg during the last 12 months * reported pathological results for differential blood count and hepatic metabolism during the last 6 months * indication for hospitalization * suicidality (assessed by madrs item 10, score ≥ 3) * iq \< 70 (clinically assessed) * any psychotropic co-medication * detention in an institution on official or judicial ruling * unwillingness to transmit pseudonym data according to german regulations * simultaneous participation in another clinical trial according to german drug law (amg)

Keywords: adhd children adolescents methylphenidate adherence immediate release extended release efficacy