Effect of methylphenidate formulation on ADHD-patients adherence to treatment MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD
Conditions
Interventions
Trade Name: Medikinet retard® 10 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298599
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Universität Mainz, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria are considered for enrolment into the trial: - 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, proven by an equally sized placebo provided by Medice® - Sufficient knowledge of the German language - Adequate contraception in case of sexual activity Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects fulfilling at least 1 of the following criteria will not be enrolled into the trial: - Contraindications against methylphenidate - Allergy or hypersensitivity against methylphenidate or methylphenidate derivate or any other ingredient of the product - Severe anxiety disorder, high tenseness or arousal, depression, psychosis - Hyperthyroidism - Glaucoma - Thyreotosicosis - Severe angina pectoris - Cardiac arrhythmia - Severe hypertension - Heart insufficiency - Myocardial infarction - Known substance abuse or alcoholism - Intake of MAO-inhibitor at the same time or during the last 14 days - Tic-disorder or tic discorder in family history - Pregnancy, lactation - Marked gastric anacidity - Previous stable methylphenidate intake more than twice daily - All severe psychiatric disorders except oppositional defiant disorder (ODD) od 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 - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure non-adherence assessed by the number of non-adherent days during the observation interval of 100 days using the Medication Event Monitoring System (MEMS).;Secondary Objective: Secondary objectives are: - To measure the duration of regular intake of the medication referring to the concept of retention (time until 30 cumulative days of non-adherence) assessed by MEMS - To measure non-adherence assessed by pill count - To measure Quality of Life assessed by the Child Health Illness Profile - child Edition (CHIP-CE) - To measure ADHD symptoms assessed by ADHD-Rating Scale IV-Parent Version (18 Items) - To measure adverse events;Primary end point(s): Primary endpoint is the number of non-adherent days during the treatment inverval measured by MEMS. | — |
Countries
Germany
Outcome results
None listed