Effect of Methylphenidate on Connectivity

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01764672
• Other study ID #: 2012-005339-95
• Secondary ID: NL42603.041.12
• Status: Withdrawn
• Phase: Phase 4
• First received: December 21, 2012
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: February 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate
Oral dose 40mg (2 x 20mg)

Other:
• Placebo
Oral intake of 2 placebo tablets

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Iris Sommer	Hersenstichting Nederland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.	To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.	After the last patient has completed the last visit, which is expected to be two years after the start of the study	No
Secondary	The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.	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.	After the last patient has completed the last visit, which is expected to be two years after the start of the study	No
Secondary	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.	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.	After the last patient has completed the last visit, which is expected to be two years after the start of the study	No