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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT03154359
Eligibility Criteria:
Inclusion Criteria:• Males and females 6-18 years of age at the time of enrollment
* Diagnosis of ADHD, as confirmed by a Study Physician at intake visit.
* Intention of the Study Physician to begin therapy with ATX at intake visit
* Willing to provide written permission/assent to participate
* ADHD Medication Status is one of the following:
* ADHD medication naïve or not currently taking ADHD medication including stimulants, α2-agonists, and ATX, or
* Currently taking a stimulant for ADHD and is willing to wash out of stimulants prior to starting ATX. This washout is also approved by a Study Physician, or other qualified study personnel (see Section 11.0 for Procedures Involved).
Exclusion Criteria:
* An IQ \< 70
* A diagnosis of Autism Spectrum Disorder
* Inability or unwillingness to have blood drawn as described in the protocol schedule of events and consent
* Underlying risk for cardiotoxicity, such as presentation of structural cardiac abnormalities, cardiomyopathy, or arrhythmias
* Clinically significant abnormal safety laboratory values as determined by treating physician
* Diagnosis that may cause abnormal absorption or gastric emptying, such as reflux, inflammatory bowel disease, or Crohn's disease
* For females, a positive urine pregnancy test
* Previous history of adverse drug reaction to ATX
* Use of drugs known to inhibit CYP2D6:
* Concurrent therapy with sertraline, venlafaxine, imipramine, nortriptyline, quinidine, propafenone, cimetidine, tamoxifen, bupropion, over-the-counter medications containing diphenhydramine, codeine, tramadol, hydrocodone, or oxycodone
* Concurrent or previous therapy with fluoxetine or paroxetine in the last 2 months
* Concurrent or previous therapy with terbinafine in the last 6 months
* Unwillingness or inability to washout of stimulant ADHD medications
* Concurrent or recent use of other psychiatric/behavioral health drugs including SSRIs, SNRIs, antipsychotics, anxiolytics, anti-epileptics, and α2-agonists that would impact the participant's pharmacokinetic and/or pharmacodynamic baseline
* Subject is considered by PI to be unsuitable for participation in the study for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT03154359
Study Brief:
Protocol Section:
NCT03154359