Effect of methylphenidate formulation on attention deficit hyperactivity disorder (ADHD)-patients' adherence to medical treatment. A comparison of Medikinet retard® (extended-release [ER]) once daily and Medikinet® (immediate-release [IR]) twice daily in children and adolescents diagnosed with ADHD
| ISRCTN | ISRCTN93724387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93724387 |
| ClinicalTrials.gov number | NCT00852059 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 05/03/2009
- Registration date
- 30/04/2009
- Last edited
- 19/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Claudia Wachtarz
Scientific
Scientific
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie
Körperschaft des öffentlichen Rechts (KöR)
Langenbeckstrasse 1
Mainz
55131
Germany
Study information
| Study design | Prospective open-label randomised active-controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of methylphenidate formulation on attention deficit hyperactivity disorder (ADHD)-patients' adherence to medical treatment. A comparison of Medikinet retard® (extended-release [ER]) once daily and Medikinet® (immediate-release [IR]) twice daily in children and adolescents diagnosed with ADHD: a prospective open-label randomised active-controlled multi-centre trial |
| Study acronym | ASTA (Adherence to stimulant treatment in ADHD-patients) |
| Study objectives | It is supposed that extended-release (ER) formulations increase treatment adherence, because children and adolescents cannot forget a second or third dose and are at lower risk to stigmatisation. |
| Ethics approval(s) | Ethics Committee of Landesärztekammer Rheinlandpfalz. Protocol Version 2.0 and Amendment 1.0 approved on 09/02/2009 (ref: 837.224.08[6221]). |
| Health condition(s) or problem(s) studied | Children and adolescents diagnosed with attention deficit hyperactivity disorder (ADHD) |
| Intervention | Before the clinical intervention, patients are observed for 4 weeks (baseline). Randomisation (ratio 1:1) to methylphenidate extended release or immediate release twice daily. Test product: Medikinet retard® (oral) Reference therapy: Medikinet® (oral) Dosage is individualised according to body weight and the dosage previously given by the paediatrician. The total duration of the clinical intervention is 100 +/- 5 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Medikinet retard® (methylphenidate), Medikinet® (methylphenidate) |
| 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). |
| Secondary outcome measures | 1. To measure the number of non-adherent days during the clinical trial assessed by MEMS at Visit 1, Visit 2 and Visit 3 2. To measure the number of non-adherent days during the clinical trial assessed by pill count at Visit 1, Visit 2 and Visit 3 3. To measure the time interval until a total number of 30 days of non-adherence (days with deviant intake behaviour) is reached cumulatively during the clinical trial, measured by MEMS at Visit 1, Visit 2 and Visit 3 4. To measure the quality of life during the clinical trial measured by Child Health Illness Profile Child Edition (CHIP-CE) Score at Visit 1, Visit 2 and Visit 3 5. To measure the efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score at Visit 1, Visit 2 and Visit 3 6. To measure the adverse events during the clinical trial measured at Visit 1, Visit 2 and Visit 3 Timepoints of assessment: Screening: within 1 week before the start of the baseline-observation Run-In-Visit: start of the baseline-observation, which takes place the four weeks before the clinical observation Visit 1: start of the clinical trial Visit 2: 50 +/- 5 days after Visit 1 Visit 3: 100 +/- 5 days after Visit 1; end of the clinical intervention |
| Overall study start date | 15/03/2009 |
| Completion date | 15/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 106 |
| Key inclusion criteria | Subjects meeting all of the following criteria are considered for enrolment into the trial: 1. Written informed consent (separately for children aged 6-11 years and 12-17 years) 2. Children and adolescents of both sexes aged 6 - 17 years 3. Confirmed diagnosis of ADHD by semi structured-clinical interview (K-SADS) 4. The ADHD Rating Scale-IV (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) 5. 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 Rating Scale (ADHD-RS) under medication, compared to retrospective ADHD-RS without medication within the past 6 months 6. Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice® 7. Sufficient knowledge of the German language 8. Adequate contraception in case of sexual activity |
| Key exclusion criteria | Subjects fulfilling any of the following criteria will not be enrolled into the trial: 1. Contraindications against methylphenidate 1.1. Allergy or hypersensitivity against methylphenidate or methylphenidate derivate or any other ingredient of the product 1.2. Severe anxiety disorder, high tenseness or arousal, depression, psychosis 1.3. Hyperthyroidism 1.4. Glaucoma 1.5. Thyreotoxicosis 1.6. Severe angina pectoris 1.7. Cardiac arrhythmia 1.8. Severe hypertension 1.9. Heart insufficiency 1.10. Myocardial infarction 1.11. Known substance abuse or alcoholism 1.12. Intake of Monoamine oxidase (MAO) inhibitor at the same time or during the last 14 days 1.13. Tic-disorder or tic disorder in family history 1.14. Pregnancy, lactation 1.15. Marked gastric anacidity 2. Previous stable methylphenidate intake more than twice daily 3. 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. 4. All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders) 5. Pathological results for vital signs, blood pressure and pulse 6. Reported pathological results for 6.1. Electrocardiogram (ECG) during the last 12 months 6.2. Differential blood count and hepatic metabolism during the last 6 months 7. Indication for hospitalization 8. Suicidality (assessed by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10, Score >=3) 9. IQ <70 (clinically assessed) 10. Any psychotropic co-medication 11. Detention in an institution on official or judicial ruling 12. Unwillingness to transmit pseudonym data according to German regulations 13. Simultaneous participation in another clinical trial according to German Drug Law (AMG) |
| Date of first enrolment | 15/03/2009 |
| Date of final enrolment | 15/08/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
55131
Germany
55131
Germany
Sponsor information
Johannes Gutenberg University of Mainz (Germany)
University/education
University/education
c/o Prof. Dr. med. Dipl.-Psych. M. Huss
Klinik u. Poliklinik für Kinder- u. Jugendpsychiatrie
Langenbeckstrasse 1
Mainz
55131
Germany
| Website | http://www.uni-mainz.de/ |
|---|---|
"ROR" |
https://ror.org/023b0x485 |
Funders
Funder type
Industry
Medice Arzneimittel Pütter GmbH & Co KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/02/2019: Clinicaltrials.gov stated that this trial was terminated by May 2014 due to low accrual.
