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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00852059
Recruitment Status : Terminated (Diffculties to recruit anticipated study size, now analysis)
First Posted : February 26, 2009
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
Prof. Huss, Johannes Gutenberg University Mainz

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:

  • prospective
  • multi-centric
  • open-label
  • randomized
  • active-controlled trial

Condition or disease Intervention/treatment Phase
ADHD Drug: Immediate release methylphenidate (Medikinet®) Drug: Extended release methylphenidate (Medikinet retard®) Phase 4

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Medikinet retard®

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of non-adherent days measured by pill count [ Time Frame: 100 days ]
  2. 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 ]
  3. Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score [ Time Frame: 100 days ]
  4. The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score [ Time Frame: 100 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00852059

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts
Mainz, Germany, 55131
Sponsors and Collaborators
Prof. Huss
Principal Investigator: Michael Huss, Prof. Dr. Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

Responsible Party: Prof. Huss, Prof. Dr. Michael Huss, Johannes Gutenberg University Mainz Identifier: NCT00852059     History of Changes
Other Study ID Numbers: JoGu_KJP_ASTA-3285-26
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Prof. Huss, Johannes Gutenberg University Mainz:
immediate release
extended release

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents