Neuroimaging of the Effects of Concerta in the Treatment of ADHD

June 8, 2012 updated by: The University of Texas Health Science Center at San Antonio

Functional Neuroimaging of Acute Concerta Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD): Differences Across Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Three age groups of subjects will be studied: school age children (aged 9-12), older adolescents (age 15-17 years) and young adults (age 20-25 years). Twenty subjects will be studied in each group. All subjects must meet criteria for ADHD, combined type and be either treatment naïve or currently taking and responding well to Concerta. Child and adolescent patients taking Concerta will have their current levels of ADHD symptoms assessed with the Dupaul ADHD rating scale (11); adults taking Concerta will be assessed with Conners Adult ADHD Rating Scale (CAARS). Patients whose symptoms are in remission as evidenced by scores in the normal range on these scales may proceed directly to the neuroimaging portion of the study. Subjects who are treatment naïve or are treated but are not in remission shall under a three week open label trial of Concerta to determine the optimal dose for treatment of their symptoms.

Subjects will have two fMRI sessions on different days. During each fMRI session, they will perform both the Stop Signal Task and the Emotional Conflict Resolution Task . On the morning of the scan, placebo and Concerta will be administered in a double-blind, crossover design, with order of medication and placebo randomized. The scan sessions will take place between 3 and 7 hours after medication administration. After each scan, the subject and a research assistant will go to a quiet room in the imaging center; the subjects will be given arithmetic level set at a level of difficulty that the subject has mastered. The subject will be given 15 minutes to complete as many problems as possible.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dept of Psychiatry, UTHSCSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets DSM-IV criteria for Attention Deficit Hyperactivity Disorder
  • Current clinical responder to Concerta (OROS-methylphenidate)

Exclusion Criteria:

  • IQ < 95
  • Presence of Learning Disorder
  • Presence of an Affective or Psychotic Disorder
  • Presence of a Substance/Alcohol Abuse/Dependence Disorder
  • Presence of an Autism Spectrum Disorder
  • Presence of a Tic Disorder
  • Taking any psychotropic medication other than Concerta
  • A medical condition requiring daily medication
  • Previous adverse or non response to Concerta

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concerta
The subject will be administered their usual dose of Concerta the morning of the FMRI scan in a double blind fashion
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.
Placebo Comparator: Placebo
The subject will be administered a placebo the morning of the FMRI scan in a double blind fashion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo
Time Frame: Placebo and Drug day, 1-2 weeks apart
Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.
Placebo and Drug day, 1-2 weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONCERTAATT4087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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