Stimulant Medication for ADHD and Tics - Understanding Response versus Non-stimulants (SATURN): a randomised trial of the clinical and cost-effectiveness of methylphenidate versus guanfacine for ADHD in children and young people with a co-existing tic disorder
Attention Deficit Hyperactivity Disorder (ADHD) and tics
Participants will be randomised to either the intervention arm in which they will be prescribed a stimulant medication (Modified-Release Methylphenidate) to be taken orally, once daily or the comparator arm in which they will be prescribed a non-stimulant medication (Guanfacine Extended-Release) to be taken orally, once daily. Treatment will be assigned randomly using a probabilistic minimisation algorithm. Allocation will be concealed using a web-based randomisation system. Randomisation results will be disclosed to participants at the baseline visit during which the first prescription will be issued and the 12-week titration period will begin. The optimal dose for each participant will be established during this 12-week period when there will be weekly (face-to-face or virtual) follow-up assessments. Subsequent follow-up assessments will take place at 24 and 52 weeks post-baseline. The research team will be responsible for prescribing during the 12 weeks period after which point it will be handed over to the participants’ usual care team. (Please note, the processes are the same for both arms).
Inclusion criteria for the young person: 1. Aged ≥6 years up to <17 years at randomisation 2. Diagnosis of ADHD by clinical team (ADHD DSM-5) confirmed by the research clinician (following review of all available information including the DAWBA) 3. Mild-moderate tics: Score >5 on the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) 4. Any ICD-10 Tic Disorder F95 (F95.0-F95.9) 5. Referred to CAMHS or community paediatrics taking part in the trial 6. Parent/carer and CYP seeking medication for ADHD (either ADHD medication naïve or seeking medication change) 7. Willing to adhere to the trial procedures= 8. If currently or recently on a different medication for ADHD or tics willing to go through or complete the appropriate wash-out period (as per standard care) to be able to receive the allocated trial IMP 9. Able to give valid, informed assent (aged <16 years) or consent (aged 16 years) 10. Able to understand and complete assessments in English 11. Eligible parent/carer willing and able to participate alongside the CYP Inclusion criteria for the parent/carer: 1. Individual with parental responsibility 2. Individual with sufficient knowledge of CYP’s medical history to be able to complete the relevant assessment tools 3. Access to reliable internet connection and email 4. Able to give valid, informed consent 5. Able to speak, understand and complete assessments in English
Exclusion criteria for the young person: 1. Current pharmacotherapy for tics 2. Current pharmacotherapy for ADHD 3. 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 guanfacine 7. Immediate risk to self or others 8. Individual who is pregnant or plans to get pregnant while in the trial 9. Individual who is breastfeeding Exclusion criteria for the parent/carer: 1. Local authority representative