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

niversity of Nottingham0 个研究点目标入组 314 人开始时间: 2022年11月30日最近更新: 2024年7月15日

适应症

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•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

发起方

niversity of Nottingham