Stimulant medication for ADHD and tics - understanding response versus non-stimulants
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD) and ticsMental and Behavioural Disorders
- Registration Number
- ISRCTN14910154
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 314
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. ADHD symptoms measured using Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at 12 weeks post-randomisation<br>2. Tics severity measured by Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) at 12 weeks post-randomisation
- Secondary Outcome Measures
Name Time Method