Effect of Methylphenidate on Connectivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

Oral dose 40mg (2 x 20mg)

Placebo

Intervention Type OTHER

Oral intake of 2 placebo tablets

Healthy adults

Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

Oral dose 40mg (2 x 20mg)

Placebo

Intervention Type OTHER

Oral intake of 2 placebo tablets

Interventions

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Methylphenidate

Oral dose 40mg (2 x 20mg)

Intervention Type DRUG

Placebo

Oral intake of 2 placebo tablets

Intervention Type OTHER

Other Intervention Names

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Ritalin

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes