Status

Recruiting patients

Lead Investigator

Professor Chris Hollis

Professor of Child and Adolescent Psychiatry

University of Nottingham

 

 

What is the study about?

Approximately 3-5% of children and young people (CYP) in the UK have Attention Deficit Hyperactivity Disorder (ADHD). Some of these CYP also experience tics. Stimulant medication (such as modified-release methylphenidate) is often prescribed to children and young people (CYP) with ADHD. However, some doctors are concerned that stimulants may increase tics and therefore, they favour prescribing non-stimulant medication (such as guanfacine extended release) to CYP with ADHD and tics. Non-stimulant medication, however, may be less effective in treating the symptoms of ADHD. With the SATURN study, we want to find out which one of these two medications, modified-release methylphenidate (stimulant medication) or guanfacine extended-release (non-stimulant medication) is better for treating CYP with both ADHD and tics.

Who can take part in the study?

Children and young people aged between 6 and 16 who have a diagnosis of ADHD but also experience tics. The child or young person needs to not be currently taking medication for their ADHD or is looking to change their medication. A parent or carer will also be asked to enrol alongside the child or young person to help them engage with and complete the study activities.

What is being tested in the study?

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)

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)

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