ADHD is a neurobehavioral developmental disorder which affects about 5% of children. In our clinical trial designed we would like to examine whether medical treatment with stimulants has an influence on autonomic nervous system parameters. Therefore children already taking their medication will be examined while ease and exertion. Children taking part must not suffer from any kind of cardiovascular desease.
Conditions
Interventions
Trade Name: Methylphenidate( Ritalin®, Medikinet®, Equasym® or Concerta®)
Pharmaceutical Form:
INN or Proposed INN: Methylphenidate
Trade Name: Atomoxetin (Strattera ®)
Pharmaceutical Form:
INN o
Sponsors
Praxis Prof. Koenig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ADHD diagnosis confirmed and already taking medication as prescribed no cardiovascular deseases age between 6-60 years no other drug intake Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ADHD diagnosis not confirmed any kind of cardiovascular disease age under 6 years or over 60 incompliance with treatment ophthalmological diseases addiction pregnancy mothers breast-feeding children allergy or hypersensitivity to drug treatment depression or other psychological disease anorexia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Attention-deficit/hyperactivity disorder (AD/HD or ADHD) is a neurobehavioral developmental disorder which affects about 5% of children with symptoms starting before seven years of age. In our clinical trial designed we would like to examine whether medical treatment with stimulants has an influence on autonomic nervous system parameters as the heart rate variability, respiratory sytem or else the pupillary light reflex. Therefore children already taking their medication will be examined while ease and exertion through manoevers like valsalva, handgrip-test, shellong-test and pupillometry. Children taking part must not suffer from any kind of cardiovascular desease affecting their autonomic nervous sytem and the diagnosis of ADHD has to be confirmed prior to measurement.;Secondary Objective: are there any differences of impact on autonomic nervous system parameters between methylphenidate versus atomoxetin? Can any age relation or correlation of sex be observed? Are the influences on heart rate variability parameteres the same in children and adolescents? ;Primary end point(s): start as soon as possible, duration time of trial 5 years end of trial for individuals who deny participation or suffer from vertigo during examination (shellong) patients who fulfil any exclusion criteria end point when no significant statistic differences between healthy and ADHD patients apparent | — |
Countries
Germany
Outcome results
None listed