Patients with Attention-Deficit/Hyperactivity Disorders (ADHD)
Conditions
Interventions
Trade Name: Strattera
Product Name: Atomoxetine
Product Code: 60775.04.00
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
RWTH Aachen Clinical Trials Center Aachen (CTC-A)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male Age 18-45 years Diagnosis of ADHD (patients) or no axis I disorder (controls) according the DSM IV No substance abuse/ dependency Understanding of the study information and declaration of agreement Ability to read, understand and speak German No severe medical disorders No risk for suicide Are the trial subjects under 18? no 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 52 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Drug dependence or the a positive drug screening Other Severe physical disorders Current pharmacological therapy because of another psychiatric disorder Risk for seizure or cardiac problems Impaired liver and renal function Significant deviations in regard to clinical chemistry, haematology or EKG Relationship of dependency with the sponsor or the investigator Unable to keep to the study protocol Known Intolerance of the study medication fMRI scanner incompatibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the changes in DMN connectivity and in fMRI BOLD response in patients with ADHD compared to healthy controls during a 2 week treatment with atomoxetine. Atomoxetine is proven to normalize the brain activity of patients with ADHD and improves their cognitive performance. One of the main aims of our study is to improve our knowledge about ADHD and its underlying neurophysiological mechanisms of functioning. Furthermore, we are planning to examine the meaning of normalized DMN activity and reward processing of patients with ADHD for an improved cognitive performance. Moreover, we are confident that the results of our study will enable us to make new interferences for future psychotherapeutic treatment. ;Secondary Objective: not applicable ;Primary end point(s): To examine the influence of atomoxetine related changes in brain activity on cognitive performance in patients with ADHD compared to controls. ;Timepoint(s) of evaluation of this end point: end of the second fMRI session | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable ;Timepoint(s) of evaluation of this end point: / | — |
Countries
Germany
Contacts
Public Contact?
RWTH Aachen Clinical Trials Center Aachen (CTC-A)
Outcome results
None listed