Effect of Methylphenidate on Connectivity

NCT01764672 | Withdrawn Phase 4

• 2 other identifiers: 2012-005339-95NL42603.041.12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Healthy Adults; Methylphenidate; Functional connectivity; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.

  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.

  After the last patient has completed the last visit, which is expected to be two years after the start of the study

Secondary Outcomes (3)

• The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.

  After the last patient has completed the last visit, which is expected to be two years after the start of the study

• The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.

  After the last patient has completed the last visit, which is expected to be two years after the start of the study

• 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.

  After the last patient has completed the last visit, which is expected to be two years after the start of the study

Study Arms (2)

Attention Deficit Hyperactivity Disorder

EXPERIMENTAL

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; Other: Placebo

Healthy adults

EXPERIMENTAL

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

Drug: Methylphenidate; Other: Placebo

Interventions

Methylphenidate DRUG

Oral dose 40mg (2 x 20mg)

Also known as: Ritalin

Attention Deficit Hyperactivity Disorder; Healthy adults

Placebo OTHER

Oral intake of 2 placebo tablets

Attention Deficit Hyperactivity Disorder; Healthy adults

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex
• Written informed consent
• For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder

You may not qualify if:

• 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)

Sponsors & Collaborators

• Iris Sommer: lead
• Netherlands Brain Foundation: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Iris EC Sommer, Prof, Dr.

  UMC Utrecht

  STUDY DIRECTOR

• Martijn P Van den Heuvel, Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 9, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

NL (1)