Information for Participants

The SNAPPER study is a clinical trial to find out how effective a stimulant medication is compared to a non-stimulant medication in patients who have been diagnoses with attention deficit hyperactivity disorder (ADHD) and also have a history of either psychosis or bipolar.

This page explains the SNAPPER study for people who may be interested in joining. Details and documents for researchers can be found on the researcher page and the documentation page.

Some questions you may have about the trial are answered below. More information is also on our participant information sheets - one for the screening visit to see if you could take part in the main trial, and another to set out what the main trial involves.

What is the background?

Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder involving inattention, hyperactivity and impulsivity, which starts in childhood and frequently persists into adulthood. ADHD in adults is commonly comorbid with bipolar disorder (bipolar) or psychosis. Stimulant and non-stimulant medication are the mainstay of treatment for ADHD in adults. The National Institute of Health and Care Evidence (NICE) ADHD guidelines recommend stimulants (Lisdexamfetamine or Methlphenidate) as first line indicators, as they are more effective then the non-stimulant Atomoxetine. NICE note an absence of data from randomised controlled trials (RCT) on the longer term effects of ADHD medications.

Who are we?

The trial is run by the University of Birmingham, and it is funded by the National Institute for Health Research, a UK health and social care research agency.

Why is this a trial?

Stimulants (Lisdexamfetamine or Methlphenidate) are used as first line medications, as they are more effective than the non-stimulant Atomoxetine as per NICE ADHD guidelines but there is lack of evidence on the long term effects of ADHD. People with psychosis or bipolar are usually excluded from ADHD trials so effectiveness in these populations is unclear. It is unknown whether stimulants or Atomoxetine vary in efficacy to improve ADHD symptoms in people with ADHD and comorbid psychosis or bipolar disorder.

What happens on the trial?

  • The research team will check if you are eligible to take part (screening).
  • You are inly included in screening and the main study if you formally agree to take part (give "informed consent").
  • We would also like to find out how supportin a close person with ADHD affects a supporter's health and lifestyle. If your nominated supporter participated in the trial (as described in the separate Screening Participant Information Sheet), you will be notified of their participation via your contact details. Please remember to tell your nominated supporter your unique trial number (TNO) as they will need this if they consent to taking part in the trial.

If you decide to take part in the main trial, the research team will ask you to do the following over the next 12 months:

  • Sign and date the main Informed Consent Form either at this visit or another visit within a week or so.
  • If you are female and of childbearing potential, you will be asked to do a urine pregnancy test again before you are entered into the trial. This is only necessary if you consent to the main trial on another day after the screening visit. This urine sample will only be used for the pregnancy test and will then be thrown away.
  • Complete some questionnaires about your mental health and ADHD before, during and after starting your medication (five times in total).
  • Complete some trial assessments with the research team before, during and after starting your medication. These will involve answering a series of questions in the form of an interview about your mental health and ADHD (five assessments in total).
  • Give the research team some details to enter you into the trial.
  • Take one of two medications that a computer will randomly allocate you to. You will have a 50/50 chance to be put in either group, like flipping a coin.
  • The research team will meet with you every 3 onths at 3, 6, 9 and 12 months. During these visits, you will be asked to repeat most of the interviews and self-reported questionnaires completed at the first visit. You will also be asked about your medication and any side effects you may have had.

Do I have to take part?

No, this is entirely up to you. Taking part is voluntary. You will not be obliged to take part in the main trial if you are suitable for it and this will not affect the standard of care you receive. You are free to withdraw at any time without giving a reason. The research team will give you £25 as a thank you for your time and support after completing the first visit, and then again after the vists at 6 and 12 months. We can also pay for your travel expenses if you had to travel to these visits. Please speak to a member of the research team for more details.

What will happen to my information?

We will only use information from you and your medical records that we need for this study. We will let very few people know your name and contact details, and only if they really need it for this study. Everyone involved in the study will keep your data safe and secure. We will also follow all privacy rules. At the end of the study we will have some of the data in case we need to check it and for future research. We will make sure no-one can make out who you are from the reports we write.

Who can I contact for more information?

You can see our participant information sheets, with further details about the trial here (SNAPPER Screening Information Sheet) and here (SNAPPER main patient information sheet). You can contact your clinical care team, or you can email us (the details are on our contact page) and we can let you know if the trial is being run in your area.