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RecruitingPhase IVInterventional

Stimulant medication for ADHD and tics - understanding response versus non-stimulants

In the UK, many children and young people live with ADHD, and about 1 in 5 also have tics. Stimulant medicines like methylphenidate are usually the first choice for ADHD. However, some doctors worry these medicines might make tics worse. Because of this, doctors often prescribe non-stimulant medicines like guanfacine instead, even though they might be less effective for ADHD. The SATURN study aims to find out which medicine works best for young people aged 6 to 16 who have both conditions. Both medicines are already approved by the NHS and recommended by national guidelines. Young people taking part are randomly assigned to take one of the two medicines. The study lasts for 12 months, featuring one clinic visit followed by regular check-ins from home. This research will help doctors and families choose the safest, most effective treatment in the future.

At a glance

Status
Recruiting
Phase
Phase IV
Sponsor
University of Nottingham
Enrolment target
314
Start
07 Mar 2023
Estimated completion
31 Jan 2027

What is this study about?

Attention deficit hyperactivity disorder (ADHD) affects how young people focus, manage energy, and control impulses. For about 1 in 5 of these children, sudden involuntary sounds or movements—known as tics—are also part of daily life. Finding the right treatment when both conditions occur together can be challenging for families and doctors.

The most common treatment for ADHD is a stimulant medication called methylphenidate. While it works very well for focus and hyperactivity, doctors sometimes worry it could make tics worse. To avoid this, doctors often turn to a non-stimulant medicine called guanfacine. Guanfacine is helpful for tics, but it may not relieve ADHD symptoms quite as well as a stimulant.

The SATURN study was created to resolve this dilemma. Researchers across England are directly comparing methylphenidate and guanfacine in children and young people aged 6 to 16. By closely tracking participants over a full year, the research team aims to see which medicine offers the best balance of symptom relief and quality of life.

Because both medicines are already widely prescribed and approved within the NHS, this study does not test brand-new drugs. Instead, it provides valuable real-world evidence so doctors and families can make informed, confident choices about care.

Key takeaways

  • Compares two standard, NHS-approved medicines for young people with ADHD and tics.
  • Open to children and young people aged 6 to 16 living in England.
  • Involves one face-to-face hospital visit, with remaining check-ins done from home.
  • Lasts 12 months with close medical support from specialist child psychiatrists.
  • Participation is voluntary, travel costs are reimbursed, and thank-you vouchers are provided.

Who may be eligible?

This study is open to children and young people aged 6 to 16 (up to their 17th birthday) who have a confirmed diagnosis of ADHD alongside mild-to-moderate tics. Families must be looking to start an ADHD medication or change their child's current prescription. Both the young person and a parent or carer must be willing to take part together.

Participants must live in England and be referred through participating NHS child and adolescent mental health services (CAMHS) or community paediatric clinics. Families will also need an email address and a reliable internet connection to complete questionnaires and attend remote appointments.

Young people cannot join if they have serious heart problems, such as high blood pressure, or a severe learning disability. They also cannot take part if they are currently taking medications for tics or ADHD that cannot safely be paused, or if they are pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child aged between 6 and 16 years old?
  2. Does your child have a clinical diagnosis of ADHD and mild-to-moderate tics?
  3. Are you looking to start or switch your child's ADHD medication?
  4. Is your child under the care of CAMHS or a community paediatric team in England?
  5. Do you have internet access and an email address for online appointments?
Answer every question to see your result.

What does participation involve?

Taking part in the SATURN study lasts for about 12 months. It begins with a short online questionnaire and a telephone screening call to check if the trial is right for your family. If eligible, you and your child will attend one face-to-face clinic visit to check their heart health, confirm eligibility, and sign consent forms.

A computer system will then randomly allocate your child to receive either methylphenidate or guanfacine. For the first 12 weeks, a researcher will check in with you weekly—mostly over phone or video calls—to see how your child is feeling and adjust the medicine dose if needed.

After 12 weeks, the team will check in again at 6 months and 12 months. Most tasks, including questionnaires, can be completed online from home. Travel costs for the clinic visit are refunded, and families receive £30 in gift vouchers plus entry into prize draws to thank them for their time.

Potential risks and benefits

Taking part may not immediately benefit your child, but it will help doctors learn which medicine works best for children with ADHD and tics in the future. Because both medications are already approved and widely used in the NHS, their side effects are well documented and will be monitored closely, including regular checks on blood pressure and heart rate. Taking part is entirely voluntary, and you can withdraw your child from the study at any time without giving a reason and without affecting their regular NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nottinghamshire Healthcare NHS Foundation Trust
    City only
    Nottingham, England

Common questions

Are these medications experimental?

No. Both methylphenidate and guanfacine are fully approved NHS medications that are regularly prescribed for children and young people in the UK.

Can we choose which medication my child gets?

No. A computer randomly decides which medicine your child receives. This ensures the trial results are fair and scientifically reliable.

How many hospital visits are required?

There is only one in-person clinic visit at the start. After that, nearly all follow-up appointments take place over the phone or video call from home.

Does taking part cost anything?

No. The trial is free, any travel expenses for the initial clinic visit are reimbursed, and families receive vouchers as a thank-you.

What happens if my child experiences side effects?

The study team monitors your child closely throughout the year. If troublesome side effects occur, the study doctor can adjust the dose or stop the medication.

How to find out more

Emily McGann

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Stimulant medication for ADHD and tics - understanding respo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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