We will test the hypothesis that ongoing use of methylphenidate is superior to placebo with regard to ADHD symptom severity in children and adolescents who have used methylphenidate for two years or longer.
ID
Bron
Verkorte titel
Aandoening
ADHD; attention deficit/hyperactivity disorder; methylphenidate; long-term effectiveness; methylfenidaat; lange termijn effectiviteit; aandachtstekortstoornis met hyperactiviteit
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
ADHD-DSM-5 RS
Doel van het onderzoek
We will test the hypothesis that ongoing use of methylphenidate is superior to placebo with regard to ADHD symptom severity in children and adolescents who have used methylphenidate for two years or longer.
Onderzoeksopzet
baseline
after four weeks
after seven weeks
Blind will be broken
fully natural follow up after six months
Onderzoeksproduct en/of interventie
The participating subjects will be randomized (ratio 1:1) to either continued use of methylphenidate or to placebo during seven weeks. Withdrawal will be gradually over a period of three weeks, followed by four weeks of complete placebo. There will be three visits, at baseline, after four weeks and after seven weeks. After six months there will be a follow up by telephone.
Algemeen / deelnemers
A.F.M. Matthijssen
Postbus 30.001
Groningen 9700 RB
The Netherlands
Tel: 050-361 55 89
a.f.m.matthijssen@umcg.nl
Wetenschappers
A.F.M. Matthijssen
Postbus 30.001
Groningen 9700 RB
The Netherlands
Tel: 050-361 55 89
a.f.m.matthijssen@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Children between the ages of eight to eighteen, any ethnicity or cultural background.
• Children with their first prescription of any form of methylphenidate at least two years ago.
• Children who are for at least the last four weeks the subject has been using methylphenidate in the form of Concerta 36 mg or 54 mg.
• Children with an IQ > 70 (based on a previous IQ test or attending regular education).
• Parents (or the legal guardian) and children (≥ twelve years) have provided informed consent to participate in the study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Excluded from participation in this study will be:
• Children who have not been using of methylphenidate for a continuous period > 2 months during the last two years.
• Children of parents who are planning to start new psychosocial or pharmacological therapies during the blinded period.
• Children and or parents who are unable to understand or comply with the protocol.
• Children who have any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5120 |
| NTR-old | NTR5252 |
| CCMO | NL49436.042.14 |
| OMON | NL-OMON41851 |