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Atomoxetine, Diurnal Profiles of Cortisol and α-amylase (ADHDstress)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075579
Recruitment Status : Unknown
Verified March 2017 by Martin Kammerer MD PhD, Praxis für kleine und grosse Leute.
Recruitment status was:  Recruiting
First Posted : March 9, 2017
Last Update Posted : March 14, 2017
Sponsor:
Collaborators:
Dr med Kurt von Siebenthal, Facharztpraxis für Pädiatrie, Winterthur, Switzerland
Dr med Roland Kägi, Facharztpraxis für Pädiatrie, Zurich, Switzerland
Dr med Corrado Garbazza, University of Basle, Switzerland
Prof Vivette Glover, Imperial College London, UK
Prof Alina Rodriguez, University of Lincoln, UK
Information provided by (Responsible Party):
Martin Kammerer MD PhD, Praxis für kleine und grosse Leute

Brief Summary:

Diurnal profiles of markers of the stress system are increasingly recognized as biomarkers of different kinds of depression and related states. They may also serve as markers of treatment success. However, this has not yet been studied in attention deficit disorder (ADHD). Especially, there is a paucity of research into the effect of ADHD medication on the diurnal profiles of cortisol as marker of the hypothalamic pituitary adrenal (HPA) system and of amylase as marker of the sympathetic adrenomedullar (SAM) system.

The investigators propose a within subjects design with probands of a narrow age range (seven to ten years of age, same sex: boys only) in order to get first information about whether there is an effect of atomoxetine on these diurnal profiles of cortisol and amylase, what kind of effect it is and whether this effect is related to treatment success. The investigators control for motor activity by using actometer measurements.


Condition or disease Intervention/treatment
ADHD Drug: Medication Other Device: motor measurement and saliva collection

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Atomoxetine, Diurnal Profiles of Cortisol and α-amylase, Possible Biological Markers of Treatment Success
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018



Intervention Details:
  • Drug: Medication Other
    medication of atomoxetine
    Other Name: atomoxetine
  • Device: motor measurement and saliva collection
    motor measurement by actometer and saliva collection for measurement of saliva cortisol and saliva alpha amylase


Primary Outcome Measures :
  1. saliva cortisol [ Time Frame: 13 weeks ]
    diurnal profile of saliva cortisol and saliva alpha amylase


Biospecimen Retention:   Samples Without DNA
Saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Boys only
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Boys are eligible, age seven to ten, dignosed with ADHD, without comorbid psychiatric and/or somatic condition for whom the responsible paediatrician and/or child psychiatrist gives the indication for treatment with atomoxetine and the parents accept their advice.
Criteria

Inclusion Criteria:

Boys are eligible, age seven to ten, without comorbid psychiatric and/or somatic condition for whom the responsible paediatrician and/or child psychiatrist gives the indication for treatment with atomoxetine.

Exclusion Criteria:

Suicidal risk, depression, history of epileptic seizures, comorbid psychiatric or somatic conditions, history of psychotropic medication.


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): NCT03075579


Contacts
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Contact: Martin Kammerer, MD PhD +4143 3880738 m.kammerer@imperial.ac.uk

Locations
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Switzerland
Dr med Kurt von Siebenthal Not yet recruiting
Winterthur, Zuerich, Switzerland, 8400
Contact: Kurt von Siebenthal, MD    +4152 260 59 60    Kurt.vonSiebenthal@monvia.ch   
Sub-Investigator: Kurt von Siebenthal, MD         
Dr med Roland Kägi Recruiting
Zurich, Switzerland, 8006
Contact: Roland Kägi, MD    +4144 250 76 50    office@rigidocs.ch   
Sponsors and Collaborators
Praxis für kleine und grosse Leute
Dr med Kurt von Siebenthal, Facharztpraxis für Pädiatrie, Winterthur, Switzerland
Dr med Roland Kägi, Facharztpraxis für Pädiatrie, Zurich, Switzerland
Dr med Corrado Garbazza, University of Basle, Switzerland
Prof Vivette Glover, Imperial College London, UK
Prof Alina Rodriguez, University of Lincoln, UK
Investigators
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Principal Investigator: Martin Kammerer, MD PHD Praxis fuer kleine und grosse Leute, Rueschlikon, Switzerland and Imperial College London
Publications:

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Responsible Party: Martin Kammerer MD PhD, Principal Investigator, Praxis für kleine und grosse Leute
ClinicalTrials.gov Identifier: NCT03075579    
Other Study ID Numbers: ADHDstress
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Martin Kammerer MD PhD, Praxis für kleine und grosse Leute:
ADHD, cortisol, α-amylase, actometer
Additional relevant MeSH terms:
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Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs