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

February 25, 2009
May 6, 2014
March 2009
December 2013   (final data collection date for primary outcome 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) [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852059 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ADHD
  • Drug: Immediate release methylphenidate (Medikinet®)
    Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
    Other Name: Medikinet®
  • Drug: Extended release methylphenidate (Medikinet retard®)
    Treatment: methylphenidate applied with breakfast(once daily), extended release
    Other Name: Medikinet retard®
  • Experimental: Immediate release
    Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)
    Intervention: Drug: Immediate release methylphenidate (Medikinet®)
  • Active Comparator: Extended release
    Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)
    Intervention: Drug: Extended release methylphenidate (Medikinet retard®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00852059
JoGu_KJP_ASTA-3285-26
No
Prof. Huss, Johannes Gutenberg University Mainz
Prof. Huss
Not Provided
Principal Investigator: Michael Huss, Prof. Dr. Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
Johannes Gutenberg University Mainz
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP