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Trial record 6 of 46 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Missouri, United States ) | NIH, U.S. Fed

Atomoxetine PBPK-PD Clinical Study

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ClinicalTrials.gov Identifier: NCT03154359
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief 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.

Condition or disease Intervention/treatment
ADHD Drug: Atomoxetine Hydrochloride

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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



Intervention Details:
  • Drug: Atomoxetine Hydrochloride
    Atomoxetine dose adjusted to achieve pre-defined concentration


Primary Outcome Measures :
  1. Pharmacodynamic - metabolomic [ Time Frame: 18 weeks ]
    Global neurotransmitter metabolome panel

  2. Pharmacodynamic - activity [ Time Frame: 18 weeks ]
    Pupillometry as surrogate for central drug action

  3. 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.

  4. Therapeutic Response (responder vs. non-responder) [ Time Frame: 18 weeks ]
    Measured by questionnaire as a dichotomous "yes/no" outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females 6-18 years of age, with a diagnosis of ADHD.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.
    • For females, a positive urine pregnancy test.
    • Previous history of adverse drug reaction to ATX.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154359


Contacts
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Contact: James S Leeder, PharmD, Phd 816-234-3059 sleeder@cmh.edu
Contact: Jaylene Weigel, RN 816-234-3059 jweigel@cmh.edu

Locations
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United States, Missouri
Children's Mercy Hospital and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Jaylene D Weigel, RN    816-701-1338    jweigel@cmh.edu   
Contact: Valentina Shakhnovich, MD    816-234-3016    vshakhnovich@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03154359     History of Changes
Other Study ID Numbers: 16100728
U54HD090258-01 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs