|- candidate number||22348|
|- NTR Number||NTR5252|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jun-2015|
|- Secondary IDs||NL49436.042.14 |
|- Public Title||Methylfenidaat afbouw studie bij kinderen|
|- Scientific Title||A multicentre randomized double-blind placebo controlled discontinuation trial of methylphenidate|
|- ACRONYM||Methylfenidaat Afbouw Studie bij Kinderen (MASK)|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||ADHD, Methylphenidat, Long term results|
|- Inclusion criteria||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.
|- Exclusion criteria||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 participants ability to participate in the study.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||31-okt-2017|
|- Target number of participants||120|
|- Interventions||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. |
|- Primary outcome||ADHD-DSM-5 RS|
|- Secondary outcome||Rating scales|
Clinical Global Impression Scale of Improvement (CGI-I).
Criteria of Oppositional Defiant Disorder (ODD)
Side en withdrawal effects based on adapted version of the Barkley Side Effect Rating scale (BSERS).
Sleep Disturbances Scale for Children (SDSC)
Appetite of the child
Retrospective Overt Aggression Scale (R-MOAS)
Parental Stress Scale (PSS)
Family atmosphere questions
Parental Frustrations Questionnaire (PFQ)
Child Depression Inventory (CDI)
Strength and Difficulties Questionnaire (SDQ).
Conners Teacher Rating Scale-Revised: short form (CTRS-R:S).
Blood draw (ferritin, zinc)
Amsterdam Neuropsychological Tasks (three subtests)
treatment history, history and compliance.
sex, age, ethnicity and school type
estimation of IQ
Tanner stage + some questions of Physical Development Scale (PDS)
Temperament (Behavioural Avoidance and Inhibition Scale [BISBAS], Inventory of Callous and Unemotional traits [ICU], Brief Sensation Seeking Scale [BSSS])
DNA (blood draw)
Cortisol from hair
Egna Minnen Betrδffende Uppfostran (EMBU)
Adult ADHD Rating scale (AARS)
Parenting Sense of Competence Scale (PSOC)
Maudsley Marital Questionnaire (MMQ)(subschale Marital adjustment)
after four weeks
after seven weeks
Blind will be broken
fully natural follow up after six months
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Msc A.F.M. Matthijssen|
|- CONTACT for SCIENTIFIC QUERIES||Msc A.F.M. Matthijssen|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||16-jun-2015 - 16-aug-2015|