Effect of Methylphenidate on Connectivity

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Hersenstichting Nederland
Information provided by (Responsible Party):
Iris Sommer, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01764672
First received: December 21, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Methylphenidate
Oral dose 40mg (2 x 20mg)
Other Name: Ritalin
Other: Placebo
Oral intake of 2 placebo tablets
Experimental: Healthy adults
Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Drug: Methylphenidate
Oral dose 40mg (2 x 20mg)
Other Name: Ritalin
Other: Placebo
Oral intake of 2 placebo tablets

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764672

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Iris Sommer
Hersenstichting Nederland
Investigators
Study Director: Iris EC Sommer, Prof, Dr. UMC Utrecht
Principal Investigator: Martijn P Van den Heuvel, Dr. UMC Utrecht
  More Information

No publications provided

Responsible Party: Iris Sommer, Prof.Dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01764672     History of Changes
Other Study ID Numbers: 2012-005339-95, NL42603.041.12
Study First Received: December 21, 2012
Last Updated: February 24, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Attention Deficit Hyperactivity Disorder
Healthy Adults
Methylphenidate
Functional connectivity
Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Hyperkinesis
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014