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Atomoxetine, Diurnal Profiles of Cortisol and α-amylase

NCT03075579 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-03-14

No results posted yet for this study

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.

Conditions

  • ADHD

Interventions

DRUG

Medication Other

medication of atomoxetine

DEVICE

motor measurement and saliva collection

motor measurement by actometer and saliva collection for measurement of saliva cortisol and saliva alpha amylase

Sponsors & Collaborators

  • Dr med Kurt von Siebenthal, Facharztpraxis für Pädiatrie, Winterthur, Switzerland

    collaborator UNKNOWN

  • Dr med Roland Kägi, Facharztpraxis für Pädiatrie, Zurich, Switzerland

    collaborator UNKNOWN

  • Dr med Corrado Garbazza, University of Basle, Switzerland

    collaborator UNKNOWN

  • Prof Vivette Glover, Imperial College London, UK

    collaborator UNKNOWN

  • Prof Alina Rodriguez, University of Lincoln, UK

    collaborator UNKNOWN

  • Praxis für kleine und grosse Leute

    lead OTHER

Principal Investigators

  • Martin Kammerer, MD PHD · Praxis fuer kleine und grosse Leute, Rueschlikon, Switzerland and Imperial College London

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2018-07-31
Completion
2018-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075579 on ClinicalTrials.gov