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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This study has been withdrawn prior to enrollment.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

December 21, 2012
February 24, 2014
April 2013
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01764672 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effect of Methylphenidate on Connectivity
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: Methylphenidate
    Oral dose 40mg (2 x 20mg)
    Other Name: Ritalin
  • Other: Placebo
    Oral intake of 2 placebo tablets
  • 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.
    Interventions:
    • Drug: Methylphenidate
    • Other: Placebo
  • Experimental: Healthy adults
    Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
    Interventions:
    • Drug: Methylphenidate
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2015
April 2015   (final data collection date for primary outcome measure)

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)
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01764672
2012-005339-95, NL42603.041.12
No
Iris Sommer, UMC Utrecht
Iris Sommer
Hersenstichting Nederland
Study Director: Iris EC Sommer, Prof, Dr. UMC Utrecht
Principal Investigator: Martijn P Van den Heuvel, Dr. UMC Utrecht
UMC Utrecht
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP