An observational study in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by NHS Tayside. Completed at 4 sites in 4 countries. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by NHS Tayside · Observational
The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade name ritalin) on growth, neurological system, psychiatric states and cardiovascular system over a two year period in children and adults.
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children, affecting approximately 5% children in Europe. Methylphenidate (MPH, trade name ritalin) is the most-commonly prescribed medication for ADHD children; it is also increasingly used in ADHD adults. In 2007, the European Commission requested a referral to the Committee for Medicinal Products for Human Use (CHMP) under Article 31 of Directive 2001/83/EC, as amended, for MPH because of safety concerns. The CHMP concluded that study of the long-term effects of MPH on growth, sexual development, neurological system, psychiatric states and cardiovascular system is needed. In response to the CHMP s concerns, the ADDUCE (Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects) research team has been formed by a consortium of experts in the fields of ADHD, drug safety, neuro-psychopharmacology and cardiovascular research.
The ADDUCE project aims to investigate the long-term adverse effects of MPH on growth, neurological system, psychiatric states and cardiovascular system in children and adults.
Furthermore the ADDUCE team will develop research tools for the evaluation of adverse effects of MPH on cognition and motivation.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 1,398 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →NHS Tayside is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Attention Deficit Disorder clinic
ADHD-treated group:
ADHD-unmedicated controls:
Non-ADHD controls:
Exclusion Criteria:
All Groups:
Un-medicated ADHD controls:
Non-ADHD controls:
Children aged 5-17 years with clinical diagnosis of ADHD and not previously treated with methylphenidate who have an agreement with their physician to begin treatment with methylphenidate.
Children aged between 5-17 years with clinical diagnosis and not previously treated with methylphenidate who have an agreement with their physician NOT to treat with methylphenidate
Any child, including siblings of a child in either the ADHD-medicated or ADHD-unmedicated control group, who is 5-17 years old. These children must have a low rating (\<1.5) on the clinician-rated Swanson Nolan and Pelham IV Rating scale (SNAP IV) and not be medicated with with either dexamfetamine or atomoxetine.
The height velocity standard deviation score
Child's height velocity-mean height velocity for sex and age / Standard deviation of height velocity for sex and age.
Time frame: 2 years
Changes in growth
* Proportion height \< 2nd centile, 0.4th centile (according to best available country specific norms) * Weight (z-scores according to best available country specific norms) * Proportion weight \< 2nd centile, 0.4th centile (according to best available country specific norms) * BMI (z-scores according to best available country specific norms) * Proportion BMI \< 2nd centile, 0.4th centile (according to best available country specific norms) * Pubertal stage (Tanner stage) * Bone age (selected sample from Italian cohort)
Time frame: 2 years
Changes to the cardiovascular system
* Heart rate * Proportion heart rate \> 120 bpm * Diastolic blood pressure * Proportion diastolic blood pressure \> 90 mm/hg * Systolic blood pressure * Proportion systolic blood pressure \> 95th centile
Time frame: 2 years
Effects on Psychiatric state
* SNAP-IV mean scores * Clinical Global Impressions score(CGI; severity, improvement) * Children's Global Assessment Scale score (CGAS) * Strengths and Difficulties questionnaire (SDQ) * Mood and Feelings Scale (parent and child ratings) * Developmental and Wellbeing Assessment * DAWBA Rapidly changing mood section (proportion \> cut off) * DAWBA tics section (proportion \> cut off) * Columbia - Suicide Severity Rating Scale * Psychosis-like symptoms * Substance Use Questionnaire
Time frame: 2 years
Changes in neurological state
* Child's Sleep Habits Questionnaire (CSHQ; total score and subscale scores, proportion \> cut offs) * Abnormal Involuntary Movement Scale (AIMS; total score, Q8 score)
Time frame: 2 years
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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NHS Tayside