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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02555150
Eligibility Criteria:
Inclusion Criteria:
Male or non-pregnant, non-nursing female at least 18 years of age and less than or equal to 25 years of age with a valid driver's license and at least six months of driving experience with driving activity at least twice per week.
ADHD diagnosis, inattentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using the Structured Clinical Interview for DSM Disorders (SCID).
Dissatisfaction with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.
Exclusion Criteria:
Known to be non-responsive to methylphenidate or lisdexamfetamine treatment. Nonresponse is defined as methylphenidate or lisdexamfetamine use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit in the last 10 years.
Having a history of motion, sea or big screen (e.g. IMAX) sickness, in order to avoid possible Simulation Adaptation Syndrome.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02555150
Study Brief:
Protocol Section:
NCT02555150