Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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:

• prospective

• multi-centric

• open-label

• randomized

• active-controlled trial

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Huss
• Treatments: Methylphenidate

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)