Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
Overview
- Phase
- Phase 4
- Intervention
- Methylphenidate
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Iris Sommer
- Locations
- 1
- Primary Endpoint
- The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
Iris Sommer
Prof.Dr.
UMC Utrecht
Eligibility Criteria
Inclusion Criteria
- •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)
Arms & Interventions
Attention Deficit Hyperactivity Disorder
Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Intervention: Methylphenidate
Attention Deficit Hyperactivity Disorder
Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Intervention: Placebo
Healthy adults
Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Intervention: Methylphenidate
Healthy adults
Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Intervention: Placebo
Outcomes
Primary Outcomes
The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)