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Psychology

Research project: Medication for ADHD in children and young people with a co-existing tic disorder (SATURN)

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NICE has included the treatment of ADHD comorbid with other conditions as a research priority.

The aim of this research is to understand whether stimulant or non-stimulant medication is most effective for treating children and young people who are experiencing both ADHD and tics. ADHD symptoms and tics are joint primary outcomes; therefore, the trial is powered for both outcomes. We aim to test whether stimulant compared with non-stimulant medication is: a) superior for ADHD symptoms: stimulants should result in a clinically important improvement in ADHD symptoms. b) non-inferior for tics: stimulants should not result in a clinically important worsening with respect to tics.

METHODS Design: Two-arm parallel group randomised comparative trial. The co-primary outcomes (ADHD symptoms and tics) will be measured at 12 weeks. The treatment period is 12 months Study population: CYP with ADHD and co-existing tics. Sample size: 314 participants (157 per arm), recruited over 24 months from 3 regional Hubs across England.

BACKGROUND: Around 3-5% of children and adolescents have attention deficit hyperactivity disorder (ADHD). Young people with ADHD find that they struggle to pay attention, have higher than usual levels of energy and their behaviour can be impulsive or unpredictable. This can lead to a young person with ADHD having difficulties at school or keeping a job. It may also result in them looking to drugs, alcohol, other substances, crime and anti-social behaviour as an expression of how they are feeling. This can lead to further mental health struggles such as anxiety and depression. Around 1 in 5 young people with ADHD also experience 'tics', which consist of uncontrolled, sudden movements of the body and sounds. This may sometimes lead to the person feeling embarrassed, isolated, and hopeless and bullied by others. These feelings can sometimes result in self-harm and the person may start to experience more mental health struggles. Early treatment is crucial to help the person cope and reduce the burden on the family and wider social and healthcare systems. Medication for ADHD is highly effective and the clinically recommended first choice medication is methylphenidate, which is a stimulant. However, there is concern amongst clinicians that using stimulant medication to treat young people with both ADHD and tics may make the young person's tics worse. As a result of this, many clinicians prefer to prescribe non-stimulant medication, which may not be as effective for treating the ADHD symptoms. AIM The aim of this research is to understand whether stimulant or non-stimulant medication is most effective for treating children and young people who are experiencing both ADHD and tics.

METHODS: We will conduct a research trial to compare stimulant medication (methylphenidate) with non-stimulant (guanfacine). Both types of medication are recommended for the treatment of ADHD. We will recruit around 314 young people aged 6-17 years old who have been diagnosed with ADHD and who also experience mild to moderate tics. Half of the young people in the study will be prescribed the stimulant medication (methylphenidate) and half will be prescribed the non-stimulant (guanfacine). Which treatment they get will be randomly decided so that the treatments can be compared. The young people will be asked to stay on their allocated medication for 12 months. However, they will be able to change or stop taking the allocated medication at any point if they, their parents or their doctors decide this would be best for them.

Principal investigator: Professor Samuele Cortese

Associated research themes

NIHR

Related research groups

Centre for Innovation in Mental Health (CiMH)
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