N/A N=42

Atomoxetine PBPK-PD Clinical Study

ADHD

Bottom Line

View on ClinicalTrials.gov: NCT03154359 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Number of Participants Classified as Responders and Non-responders to Intervention — 14; 15 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Atomoxetine Hydrochloride (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: Children's Mercy Hospital Kansas City
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Classified as Responders and Non-responders to Intervention	13; 7	—
PRIMARY Number of Participants Classified as Responders and Non-responders to Intervention	13; 7	—
PRIMARY Maximum Plasma Concentration (Cmax) of Atomoxetine	601.3; 375.5	0.147
PRIMARY Maximum Plasma Concentration (Cmax) of Atomoxetine	601.3; 375.5	0.147
PRIMARY Maximum Plasma Concentration (Cmax) of Atomoxetine	601.3; 375.5	0.147
PRIMARY Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine	3149.2; 2880.0	0.759
PRIMARY Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine	3149.2; 2880.0	0.759
PRIMARY Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine	3149.2; 2880.0	0.759
PRIMARY Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)	0.323; 0.283	0.539
PRIMARY Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)	0.323; 0.283	0.539
PRIMARY Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)	0.323; 0.283	0.539
PRIMARY Change in Plasma Concentration of DHPG From Baseline	-0.059; -0.081	0.652
PRIMARY Change in Plasma Concentration of DHPG From Baseline	-0.059; -0.081	0.652

Summary

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03154359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.