Electrophysiological correlates of putative endophenotypes of attention-deficit / hyperactivity disorder (ADHD)

Conditions: Attention-deficit hyperactivity disorder (ADHD)

Registration Number: EUCTR2008-001291-71-DE

Lead Sponsor: niversity of Wuerzburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?).<br>;Primary end point(s): Neurophysiological measures at day 28 (NGA and SICI).

Secondary Outcome Measures