|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03075579 |
|
Date of registration:
|
06/03/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Atomoxetine, Diurnal Profiles of Cortisol and a-amylase
ADHDstress |
|
Scientific title:
|
Atomoxetine, Diurnal Profiles of Cortisol and a-amylase, Possible Biological Markers of Treatment Success |
|
Date of first enrolment:
|
December 1, 2016 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03075579 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Martin Kammerer, MD PHD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Praxis fuer kleine und grosse Leute, Rueschlikon, Switzerland and Imperial College London |
|
|
Name:
|
Martin Kammerer, MD PhD |
|
Address:
|
|
|
Telephone:
|
+4143 3880738 |
|
Email:
|
m.kammerer@imperial.ac.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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.
Age minimum:
7 Years
Age maximum:
10 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
ADHD
|
|
Intervention(s)
|
|
Drug: Medication Other
|
|
Device: motor measurement and saliva collection
|
|
Primary Outcome(s)
|
|
saliva cortisol
[Time Frame: 13 weeks]
|
|
Secondary ID(s)
|
|
ADHDstress
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|