MedTrace Logo

Neuroimaging of the Effects of Concerta in the Treatment of ADHD

NCT00778310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-07-13

Study results available
· View outcomes & findings →

Summary

A number of brain regions have been down to be altered in both structure and function in patients with ADHD, including prefrontal cortex, anterior cingulate, caudate and cerebellum. Patients with ADHD often show reduced levels of activity in the frontal and cingulate regions of brain while performing measures of inhibitory control during functional magnetic resonance imaging (fMRI). While stimulant medications robustly improve the clinical symptoms of ADHD, there are only a small number of studies examining the effects of these commonly prescribed medications on brain activity. We propose to obtain fMRI in patients with ADHD on placebo and on their individualized dose of OROS methylphenidate (Concerta). Our hypothesis is that Concerta will increase the activity of the brain in the frontal, cingulate and amygdala of the brain and that these brain changes will be associated with clinical improvement of symptoms.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

methylphenidate-OROS

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of Concerta that are made to appear similar to placebo capsules. The subject will be administered their usual dose of Concerta the morning of the scan.

DRUG

Placebo

The collaborator (Ortho-McNiel Janssen Scientific Affairs, LLC) will provide capsules of placebo that are made to appear similar to Concerta capsules. The subject will be administered placebo the morning of the scan.

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Steven R Pliszka, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778310 on ClinicalTrials.gov