EUCTR2008-003285-26-DE
Active, not recruiting
Not Applicable
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
niversität Mainz, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie0 sitesJune 24, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Effect of methylphenidate formulation on ADHD-patients adherence to treatment
- Sponsor
- niversität Mainz, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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