Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Johannes Gutenberg University Mainz.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johannes Gutenberg University Mainz
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00852059
First received: February 25, 2009
Last updated: April 7, 2009
Last verified: April 2009
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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 ]
| Estimated Enrollment: | 106 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852059
Contacts
| Contact: Michael Huss, Prof. Dr. | 0049-6131-17- ext 3281 | michael.huss@ukmainz.de |
Locations
| Germany | |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Michael Huss, Prof. Dr 0049-6131-17- ext 3281 michael.huss@ukmainz.de | |
| Sub-Investigator: Claudia Wachtarz, Dipl.-Psych. | |
| Sub-Investigator: Birte Behn, Dr. med. | |
| Kinderneurologisches Zentrum Mainz (KINZ) | Recruiting |
| Mainz, Germany | |
| Contact: Helmut Peters, Dr. med. H.Peters@kinzmainz.de | |
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
| Principal Investigator: | Michael Huss, Prof. Dr. | Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry |
More Information
No publications provided
| Responsible Party: | Michael Huss/ Prof. Dr. med. Dipl.-Psych., Johannes Gutenberg University Mainz, Dep. of Child and Adolescent Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00852059 History of Changes |
| Other Study ID Numbers: | JoGu_KJP_ASTA-3285-26 |
| Study First Received: | February 25, 2009 |
| Last Updated: | April 7, 2009 |
| 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 Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013