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

ADHD Clinical Trial

Official title: 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

Status Terminated

Clinical Trial 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

Clinical Trial 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 are recruited in two centres. Over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. In the subsequent controlled clinical trial 50% of the participants are randomized to extended release (ER) methylphenidate (Medikinet retard®) applied with breakfast, 50% are randomized to immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (clinical trial). To optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded.

According to the power calculation 106 patients will be randomized. The total duration of the study is 18 months. Starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. Subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. Medical care is provided in the routine program of both study centres. To record the adherence, medication events are counted by Medication Event Monitoring System (MEMS). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

• NCT number: NCT00852059
• Study type: Interventional
• Source: Johannes Gutenberg University Mainz
• Status: Terminated
• Phase: Phase 4
• Start date: March 2009
• Completion date: December 2013