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Contact Information:

Prof Chris Hollis
+44 (0)115 823 0258
chris.hollis@nottingham.ac.uk


Mrs Emily McGann
+44 (0)1158231600
saturn@nottingham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Stimulant medication for ADHD and tics - understanding response versus non-stimulants
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Stimulant medication for ADHD and tics - understanding response versus non-stimulants

Recruiting

Open to: All Genders

Age: Child

Nottingham

Medical Conditions

Attention Deficit Hyperactivity Disorder (ADHD) and tics

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In the UK, 3-5% of children and young people (CYP) have attention deficit hyperactivity disorder (ADHD). Out of those, 1 in 5 also experiences 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

07 Mar 2023 31 May 2026

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).


Children and young people (6-16 years old) with ADHD and tics will be recruited in England.

You can take part if:



You may not be able to take part if:


Exclusion criteria for the young person:1. Current pharmacotherapy for tics2. Current pharmacotherapy for ADHD3. Abnormal cardiovascular examination (e.g., BP >95th percentile, tachycardia)4. Diagnoses of alcohol/substance dependence, psychosis or mania (as per clinician judgement)5. Intellectual disability (clinical estimate of IQ <70) (confirmed by Child and Adolescent Intellectual Disability Screening Questionnaire; CAIDS-Q)6. Contraindications to MR-MPH and guanfacine7. Immediate risk to self or others8. Individual who is pregnant or plans to get pregnant while in the trial9. Individual who is breastfeeding

Exclusion criteria for the parent/carer:1. Local authority representative


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nottinghamshire Healthcare NHS Foundation Trust
    The Resource, Trust Hq Duncan Macmillan House Porchester Road
    Nottingham
    NG3 6AA

The researchers cannot promise that taking part in this study will benefit the participants personally. The main benefit of this research is that the researchers will learn more about which medication is best to help children and young people with ADHD and tics, which may mean getting the right help is easier for children and young people in the future.
Both groups will receive a treatment (medication) that has been approved for this use in this age group. Both treatments are commonly prescribed in our target population and are recommended by NICE (methylphenidate as first-line treatment for ADHD while guanfacine as the first-line treatment for tics and second-line treatment for ADHD). The inclusion/exclusion criteria exclude participants with contraindications to either of the trial medications and concomitant medications and treatments are closely monitored while in the trial. Baseline measures include a cardiovascular exam and participants with increased cardiovascular risk based on the exam and the relevant EAGG guidance will be considered for exclusion. Those that are included in the trial will be allocated to the ‘enhanced monitoring group’ and will be asked to provide Blood Pressure (BP) and pulse measurements frequently (frequency to be determined by the research clinician). The trial has undergone a risk assessment by the Nottingham Clinical Trials Unit (NCTU) and the overall risk categorisation is low.
The trial will employ at least one research clinician and research assistant (they may be referred to as researcher or research support officer elsewhere) per regional hub who will be appropriately trained and will have frequent contact with the trial participants (weekly during the titration phase and then at approximately 6- and 12- months following randomisation). The research clinicians and research assistants will be supervised by the regional hub leads who are experienced child and adolescent psychiatrists. The hub leads are experienced clinical leads who have been involved in the grant application and protocol development as co-applicants and have an in-depth knowledge of the trial as well as the target population.
As both medications have marketing authorisation for this use in this population, side effects are known and well documented. Adverse event data will be collected until the end of the participant’s involvement in the trial (approx. 12 months). Any serious adverse events will be reported timely (within 24 hours of becoming aware) and monitored until the event is resolved.
Risk of inconvenience or discomfort: Families who travel to attend their Baseline Visit will be reimbursed for any travel costs, even if they are not enrolled in the trial. Apart from Visit 1, participants will be able to complete other measures and questionnaires at their home in their own time (as close to the agreed timepoint as possible) when it is most convenient to them. Where questionnaire data need to be obtained by a researcher a phone call/Teams call will be arranged at a time that suits.
Additionally, families will receive a total of £30 in vouchers and will be entered in up to six prize draws as a small token of appreciation for their time to complete baseline and follow-up measures.
Risk of breach of confidentiality: All members of the research team will have undergone GCP training. No personal information will be sent to the research team prior to receiving a ‘consent to contact’ form from the parent/carer. The REDCap database is designed so only relevant members of the research team can see the outcome measures of their participants. It is a validated secure web-based platform which allows for data tracking via date-stamped audit logs.
Participant data will be identified only by their unique trial ID number to protect from bias and ensure confidentiality.

Prof Chris Hollis
+44 (0)115 823 0258
chris.hollis@nottingham.ac.uk


Mrs Emily McGann
+44 (0)1158231600
saturn@nottingham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Nottingham and funded by Health Technology Assessment Programme.



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Read full details for Trial ID: ISRCTN14910154

Or CPMS 53869

Last updated 28 April 2025

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