Stimulant Medication for ADHD and Tics - Understanding Response versus Non-stimulants (SATURN)
Research type
Research Study
Full title
Stimulant Medication for ADHD and Tics - Understanding Response versus Non-stimulants (SATURN): a randomised trial of the clinical and cost-effectiveness of methylphenidate versus guanfacine for ADHD in children and young people with a co-existing tic disorder
IRAS ID
1005480
Contact name
Chris Hollis
Contact email
Sponsor organisation
University of Nottingham
Eudract number
2022-002425-10
ISRCTN Number
ISRCTN14910154
Research summary
In the UK, 3-5% of children and young people (CYP) have attention deficit hyperactivity disorder (ADHD). Out of those, 1 in 5 also experience tics. Stimulant medication is effective for ADHD, however, there is concern among doctors that it may worsen children/young people’s tics. As a result, they prefer to prescribe non-stimulants which may be less effective for ADHD to CYP who suffer from both ADHD and tics.
The aim of the SATURN trial is to understand whether stimulant or non-stimulant medication is the most effective in children and young people (6-16 years old) with ADHD and tics.
The medications that are being studied are:
1) modified-release (MR) methylphenidate (stimulant). Methylphenidate is the first-line treatment recommended by the National Institute for Health and Care Excellence (NICE) for ADHD and the most commonly prescribed medication in this population.
2) guanfacine extended-release (non-stimulant). Guanfacine is the first-line treatment recommended by NICE for tic disorders and second-line for ADHD.
314 children and young people will be recruited in England. Parents/carers who express an interest in their children/young people taking part will be asked to complete a pre-screening questionnaire - the Development and Wellbeing Assessment (DAWBA). Eligible families will undergo a screening call with a researcher and those who are eligible and would like to take part, will have their baseline visit scheduled.
During this visit, which is face-to-face, eligibility will be confirmed, consent will be taken (parent and 16-year-old) and assent where applicable (children/young people 6-15 years old) and baseline questionnaire data and measurements will be collected. Participants will be randomly allocated to one of the two medications and will be seen weekly (mainly remotely) for 12 weeks and again at approximately six months and 12 months from randomisation (end of participation).REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0283
Date of REC Opinion
24 Nov 2022
REC opinion
Further Information Favourable Opinion