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

This study has been terminated.
(Diffculties to recruit anticipated study size, now analysis)
Sponsor:
Information provided by (Responsible Party):
Prof. Huss, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00852059
First received: February 25, 2009
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
ADHD
Drug: Immediate release methylphenidate (Medikinet®)
Drug: Extended release methylphenidate (Medikinet retard®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of non-adherent days measured by pill count [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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).

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852059

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

No publications provided

Responsible Party: Prof. Huss, Prof. Dr. Michael Huss, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT00852059     History of Changes
Other Study ID Numbers: JoGu_KJP_ASTA-3285-26
Study First Received: February 25, 2009
Last Updated: May 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
ADHD
children
adolescents
methylphenidate
adherence
immediate release
extended release
efficacy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014