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| ID | Type | Description | Link |
|---|---|---|---|
| NL42603.041.12 | Registry Identifier | Toetsingonline |
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| Name | Class |
|---|---|
| Netherlands Brain Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Deficit Hyperactivity Disorder | Experimental | Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days. |
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| Healthy adults | Experimental | Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Oral dose 40mg (2 x 20mg) |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo. | 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. | After the last patient has completed the last visit, which is expected to be two years after the start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls. | To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls. | After the last patient has completed the last visit, which is expected to be two years after the start of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris EC Sommer, Prof, Dr. | UMC Utrecht | Study Director |
| Martijn P Van den Heuvel, Dr. | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
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| 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 |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Other | Oral intake of 2 placebo tablets |
|
| The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate. | 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. | After the last patient has completed the last visit, which is expected to be two years after the start of the study |
| 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. | 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. | After the last patient has completed the last visit, which is expected to be two years after the start of the study |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |