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

May 6, 2014 updated by: Prof. Huss

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate release
Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)
Drug: Immediate release methylphenidate (Medikinet®)
Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
Other Names:
  • Medikinet®
Active Comparator: Extended release
Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)
Drug: Extended release methylphenidate (Medikinet retard®)
Treatment: methylphenidate applied with breakfast(once daily), extended release
Other Names:
  • Medikinet retard®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)
Time Frame: 100 days
100 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of non-adherent days measured by pill count
Time Frame: 100 days
100 days
Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS
Time Frame: 100 days
100 days
Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score
Time Frame: 100 days
100 days
The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score
Time Frame: 100 days
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Huss

Investigators

  • Principal Investigator: Michael Huss, Prof. Dr., Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JoGu_KJP_ASTA-3285-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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