Clinical trial NCT01764672: Effect of Methylphenidate on Connectivity
Official title: Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Healthy Adults
Methylphenidate
Functional connectivity
Functional Magnetic Resonance Imaging
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Netherlands Brain Foundation
First posted: 2013-01-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
timeFrame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
Secondary outcomes:
measure: The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.
timeFrame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
measure: The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
timeFrame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
measure: 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.
timeFrame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Iris EC Sommer, Prof, Dr.
role: STUDY_DIRECTOR
affiliation: UMC Utrecht
name: Martijn P Van den Heuvel, Dr.
role: PRINCIPAL_INVESTIGATOR
References: