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

Primary Purpose

ADHD

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Immediate release methylphenidate (Medikinet®)
Extended release methylphenidate (Medikinet retard®)
Sponsored by
Prof. Huss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, children, adolescents, methylphenidate, adherence, immediate release, extended release, efficacy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate release

Extended release

Arm Description

Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)

Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)

Outcomes

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2009
Last Updated
May 6, 2014
Sponsor
Prof. Huss
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1. Study Identification

Unique Protocol Identification Number
NCT00852059
Brief Title
Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
Acronym
ASTA
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Diffculties to recruit anticipated study size, now analysis
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Huss

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, children, adolescents, methylphenidate, adherence, immediate release, extended release, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate release
Arm Type
Experimental
Arm Description
Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)
Arm Title
Extended release
Arm Type
Active Comparator
Arm Description
Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)
Intervention Type
Drug
Intervention Name(s)
Immediate release methylphenidate (Medikinet®)
Other Intervention Name(s)
Medikinet®
Intervention Description
Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
Intervention Type
Drug
Intervention Name(s)
Extended release methylphenidate (Medikinet retard®)
Other Intervention Name(s)
Medikinet retard®
Intervention Description
Treatment: methylphenidate applied with breakfast(once daily), extended release
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of non-adherent days measured by pill count
Time Frame
100 days
Title
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
Title
Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score
Time Frame
100 days
Title
The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Huss, Prof. Dr.
Organizational Affiliation
Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts
City
Mainz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

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

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