Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT03333668
Eligibility Criteria:
Inclusion Criteria:
* Age range: 8-20 years
* Medication-naïve or non-medicated for two weeks or on stimulant medication, and willing to take the medication off for 48 hours before scans.
* Meeting DSM-5 diagnosis of ADHD
* Score above clinical cut-off on the ADHD module of the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) (Kaufman et al., 1997)
* Score above clinical cut-off for ADHD on the short forms of the Conners Parent Rating Scales, CPRS (Conners et al., 2008)
* Score above cut-off on the ADHD Rating Scale, ADHD-RS (DuPaul, et al., 1998)
* IQ \> 70 as tested on the WASI-II (Wechsler et al., 1999)
* Mood and depression symptoms will be allowed as long as they are not the primary diagnosis.
Exclusion Criteria:
* IQ \< 70 (Wechsler et al., 1999).
* Comorbidity with schizophrenia, bipolar disorder, learning disability, OCD, severe depression with current suicidal behaviour (as assessed by a clinical interview)
* Neurological problems, i.e. a history of severe neurological illness, e.g. brain tumour, epilepsy or a history of symptomatic seizures, polyneuropathy etc.
* Substance abuse history
* Other illness (cardiovascular, renal, hepatic, metabolic) that would impact the data integrity or safety of the subject (i.e. contraindicated to any of the treatments) as determined by the investigators
* Contraindication to MRI. i.e., previous implantation of metallic material, pacemaker, implanted medication pumps, neural stimulators, claustrophobia
* Unable to give informed assent or consent in the case of the parent
* Contraindications for LISDEX and GXR use (i.e. advanced arteriosclerosis, agitated states, hyperexcitability, hyperthyroidism, moderate or severe hypertension, symptomatic cardiovascular disease)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
20 Years
Study:
NCT03333668
Study Brief:
Protocol Section:
NCT03333668