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The primary aims of this study focus on characterizing the relationship between atomoxetine exposure and clinical outcomes, as assessed by standardized measures. We will also simultaneously monitor side effect of atomoxetine, another measure of clinical outcomes, and categorize study participants on their ability to tolerate atomoxetine.
An Open-Label, Single- and Multi-Dose Study to Evaluate the Relationship Between the Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of Atomoxetine in CYP2D6 Extensive, Intermediate, and Poor Metabolizers in Children With Attention Deficit/Hyperactivity Disorder
Actual Study Start Date :
December 12, 2017
Estimated Primary Completion Date :
June 30, 2022
Estimated Study Completion Date :
June 30, 2022
Resource links provided by the National Library of Medicine
Pharmacodynamic - metabolomic [ Time Frame: 18 weeks ]
Global neurotransmitter metabolome panel
Pharmacodynamic - activity [ Time Frame: 18 weeks ]
Pupillometry as surrogate for central drug action
Incidence of adverse events [ Time Frame: 18 weeks ]
Cardiovascular safety will be assessed by examining elevations in heart rate and blood pressure pre vs. post-treatment. The parent and teacher medication side effect questionnaire will also be used to assess whether or not the intervention resulted in clinically unacceptable adverse events. All adverse events will be reported in the same units, specifically the number of children experiencing the event.
Therapeutic Response (responder vs. non-responder) [ Time Frame: 18 weeks ]
Measured by questionnaire as a dichotomous "yes/no" outcome.
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Layout table for eligibility information
Ages Eligible for Study:
6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Males and females 6-18 years of age, with a diagnosis of ADHD.
Males and females 6-18 years of age
Diagnosis of ADHD.
It is the intention of the treating physician to begin therapy with atomoxetine (ATX).
ADHD-medication naïve or willing to undergo a two week wash out period.
Willing to provide written permission/assent to participate.
• An IQ < 70.
A diagnosis of Autism Spectrum Disorder.
Inability or unwillingness to have blood drawn.
Concurrent therapy with drugs known to inhibit CYP2D6 and unwilling or unable to undergo a washout period. This includes medications such as fluoxetine, sertraline, paroxetine, venlafaxine, imipramine, nortriptyline, quinidine, propafenone, cimetidine, tamoxifen, bupropion, over-the-counter medications containing diphenhydramine, codeine, tramadol, hydrocodone, or oxycodone.
Previous treatment with strong CYP2D6 inhibitors, such as fluoxetine or paroxetine (two month wash-out required), or terbenafine (six month wash-out required).
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
Presentation of diagnosis that may cause abnormal absorption or gastric emptying, such as reflux, inflammatory bowel disease, or Crohn's disease.