Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging
Brief summary
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.
Interventions
DRUGMethylphenidate
Oral dose 40mg (2 x 20mg)
OTHERPlacebo
Oral intake of 2 placebo tablets
Sponsors
Netherlands Brain Foundation
Iris Sommer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Male sex * Written informed consent * For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder
Exclusion criteria
* Age under 18 or \> 40 * Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group) * Use of psychotropic medication * Use of recreational drugs in the two weeks before start of the study * Consuming an equivalent of \> 5 cups of coffee per day * Consuming three or more alcohol units per day * The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic * Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo. | After the last patient has completed the last visit, which is expected to be two years after the start of the study | The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in this study, is whether, and if so to what extent, methylphenidate affects the organization of brain networks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls. | After the last patient has completed the last visit, which is expected to be two years after the start of the study | To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls. |
| The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate. | After the last patient has completed the last visit, which is expected to be two years after the start of the study | To examine how a reorganization of brain networks as described in the primary objective is related to improvements in cognitive performance and to blood levels of methylphenidate. |
| The correlation of whole brain cortical thickness and white matter volume as measured with Magnetic Resonance Imaging with both graph metrics as measured with functional Magnetic Resonance Imaging and scores on cognitive tests. | After the last patient has completed the last visit, which is expected to be two years after the start of the study | To examine if certain network structures of the brain, such as cortical thickness and white matter volume, are related to susceptibility to medication efficacy and if the structural qualities are related to cognitive performance. |
Countries
Netherlands
Outcome results
None listed