Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00852059
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT00852059
Study Brief:
Protocol Section:
NCT00852059