Effect of methylphenidate formulation on ADHD-patients' adherence to medical treatment. A comparison of Medikinet retard® (ER) once daily and Medikinet® (IR) twice daily in children and adolescents diagnosed with ADHD - Adherence to stimulant treatment in ADHD-patients
- Conditions
- Effect of methylphenidate formulation on ADHD-patients adherence to treatmentMedDRA version: 9.1Level: LLTClassification code 10064104Term: ADHD
- Registration Number
- EUCTR2008-003285-26-DE
- Lead Sponsor
- niversität Mainz, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>- 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<br>- To measure non-adherence assessed by pill count<br>- To measure Quality of Life assessed by the Child Health Illness Profile - child Edition (CHIP-CE)<br>- To measure ADHD symptoms assessed by ADHD-Rating Scale IV-Parent Version (18 Items)<br>- To measure adverse events;Primary end point(s): Primary endpoint is the number of non-adherent days during the treatment inverval measured by MEMS.
- Secondary Outcome Measures
Name Time Method