Effect of Methylphenidate on Connectivity

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Methylphenidate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Deficit Hyperactivity Disorder<br>Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days. | Drug: Methylphenidate<br>* Oral dose 40mg (2 x 20mg)<br>* Other names: Ritalin;Other: Placebo<br>* Oral intake of 2 placebo tablets<br>|
| Experimental: Healthy adults<br>Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days. | Drug: Methylphenidate<br>* Oral dose 40mg (2 x 20mg)<br>* Other names: Ritalin;Other: Placebo<br>* Oral intake of 2 placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging