Study name: SATURN Status: Set-up
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
Professor Chris Hollis
What is the study about?
The aim of this research is to compare the clinical and cost-effectiveness of stimulant (modified-release methylphenidate) with non-stimulant medication (guanfacine extended release) in treating children and young people who are experiencing both ADHD and tics.
Who can take part in the trial?
Patients aged ≥6 years up to <17 years at randomisation with a diagnosis of ADHD and tics who are not taking medication for ADHD or are looking to change their medication.A parent/carer of each patient will also be asked to enrol in the study to help them engage in and undertake all study activities.
What is being tested in the trial?
Stimulant medication - once daily Modified-Release Methylphenidate.
What is this being compared to?
Non-stimulant medication - once daily Guanfacine Extended Release.
What are we trying to find out?
The aim of the study is to test whether Modified Release Methylphenidate is more effective than Guanfacine Extended-Release in improving ADHD symptoms but without worsening tics. The cost-effectiveness of the two medications will also be assessed.
How many patients do we need?
314 participants (157 per arm)