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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01913912
Eligibility Criteria:
Inclusion Criteria:
* Children with ADHD (male and female)
* Age: form 7 years old until the end of 12 years old at screening
* Official diagnosis of ADHD (one of the three subtypes) as confirmed by administration of the Diagnostic Interview Scale for Children for DSM-IV (DISC-IV) interview at screening
* No prior use of stimulant medication (Drug naïve)
Exclusion Criteria:
* Comorbid disorders (severe anxiety or mood disorder, Autism Spectrum Disorder, Conduct disorder, Tic disorder, other major psychiatric pathologies)
* Other neurological disorder or chronic illness/disability
* Intelligence quotient (IQ) below 80
* Body weight below 22.7 kg
* Use of a psychoactive medication (especially use of monoamine oxidase inhibitors (MAOI))
* History of cardiac disease, family history of premature (sudden/unexpected) death in children or young adults, hypertrophic cardiomyopathy, clinically important arrhythmias including long QT syndrome (LQTS), Marfan syndrome
* Abnormal findings on physical examination indicating cardiac disease
* Glaucoma
* Sensitive or allergic to stimulants or other ingredients of LDX
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT01913912
Study Brief:
Protocol Section:
NCT01913912