Status:
TERMINATED
Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
Lead Sponsor:
Prof. Huss
Conditions:
ADHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief 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: * ...
Detailed Description
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00852059
Start Date
March 1 2009
End Date
December 1 2013
Last Update
May 7 2014
Active Locations (1)
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1
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts
Mainz, Germany, 55131