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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002386-18 | EudraCT Number |
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Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of life. It is suggested that those symptoms can be attributed to a general deficit in inhibitory control. This hypothesis is supported by several studies revealing that patients with ADHD show poor performance completing inhibitory control tasks.
Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly improves inhibitory control in patients with ADHD as well as in healthy participtants. In contrast to other medication authorized for the treatment of patients with ADHD, does ATX has no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.
Although we directly often associate failures in cognitive control with disruptions at prefrontal areas of the brain, there exists a specific brain network which is called the default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD symptomatic.
The following study is interested in which way a 2- week intake of ATX affects the DMN and surrounding networks in their connectivity during a inhibitory control task and during rest in patients with ADHD vs controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First placebo, than atomoxetin | Experimental | Patients receive a placebo in the first of the two 14-day treatment intervals and atomoxetin in the second 14-day treatment intervals. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. |
|
| First atomoxetin, than placebo | Experimental | Patients receive atomoxetin in the first of the two 14-day treatment intervals and a placebo in the second 14-day treatment interval. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | 14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills) |
|
| Measure | Description | Time Frame |
|---|---|---|
| FMRT resting state connecitivty of the default mode network | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital RWTH Aachen | Aachen | 52074 | Germany |
Data will be uploaded into the data pool of the Deutsches Netzwerk zu psychischen Erkrankungen.
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|
| Placebos | Drug | 14-day treatment interval: first week one placebo pill, second week two placebo pills |
|
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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