- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764672
Effect of Methylphenidate on Connectivity
February 24, 2014 updated by: Iris Sommer
Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utrecht, Netherlands, 3584 CX
- UMC Utrecht
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Oral dose 40mg (2 x 20mg)
Other Names:
Oral intake of 2 placebo tablets
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Experimental: Healthy adults
Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
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Oral dose 40mg (2 x 20mg)
Other Names:
Oral intake of 2 placebo tablets
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What is the study measuring?
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.
Time Frame: 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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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.
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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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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.
Time Frame: 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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To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.
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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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The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
Time Frame: 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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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.
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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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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.
Time Frame: 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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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.
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Iris EC Sommer, Prof, Dr., UMC Utrecht
- Principal Investigator: Martijn P Van den Heuvel, Dr., UMC Utrecht
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
April 1, 2015
Study Registration Dates
First Submitted
December 21, 2012
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimate)
January 9, 2013
Study Record Updates
Last Update Posted (Estimate)
February 26, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- 2012-005339-95
- NL42603.041.12 (Registry Identifier: Toetsingonline)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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