Attention-deficit hyperactivity disorder (ADHD)
Conditions
Interventions
Trade Name: Strattera
Product Name: Strattera
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atomoxetinhydrochlorid
CAS Number: 83015-26-3
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
University of Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age 10 - 50 years • DSM-IV criteria of ADHD must be met (during childhood and actual) 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: • significant psychiatric axis-I comorbidities (bipolar disorder, psychosis, depression, drug addiction) • suicidal tendencies • epilepsy • metal parts in the head, heart pacemakers • pregnancy • severe medical comorbidities (cardiovascular or cerebrovascular illnesses, liver and kidney diseases; hyperthyreosis) • pre-treatment with methylphenidate or atomoxetine • known incompatibility of methyphenidate or atomoxetine • intake of MAO-inhibitors within the last 14 days prior to pharmacological challenge • actual treatment with other psychiatric medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To replicate previous findings on an influence of COMT-genotype (Val158Met) on a topographical ERP parameter of prefrontal functioning (NGA) in ADHD, and to extend these findings to TMS measures (cortical inhibition and facilitation).;Secondary Objective: To examine the effect of an acute MPH / ATX challenge on the dependent variables (NGA, ICI, ICF). To examine additional influences of COMT-genotype on the response to such a pharmacological challenge in ADHD patients (differential effect in different genotype groups due to different monoaminergic metabolisms?). To examine influences of a continued therapy with MPH or ATX on neurophysiological (NGA, ICI, ICF) and behavioural parameters in ADHD patients generally, and more specifically for different COMT genotype groups and in responders vs. non-responders of the pharmacological challenge (predictive value of response to challenge?). ;Primary end point(s): Neurophysiological measures at day 28 (NGA and SICI). | — |
Countries
Germany
Outcome results
None listed