Neuroimaging of the Effects of Concerta in the Treatment of ADHD
Information source: The University of Texas Health Science Center at San Antonio
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: methylphenidate-OROS (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The University of Texas Health Science Center at San Antonio Official(s) and/or principal investigator(s):
Steven R Pliszka, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio
Overall contact:
Steven R Pliszka, MD, Phone: 210-567-5475, Email: pliszka@uthscsa.edu
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.
Clinical Details
Official title: Functional Neuroimaging of Acute Concerta Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD): Differences Across Development
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Brain Oxygenation Level Dependent Signal in the frontal and cingulate cortex and the amygdala on Concerta vs. Placebo
Secondary outcome: Number of math problems completed on day of scan
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.
Eligibility
Minimum age: 9 Years.
Maximum age: 25 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Steven R Pliszka, MD, Phone: 210-567-5475, Email: pliszka@uthscsa.edu
Dept of Psychiatry, UTHSCSA, San Antonio, Texas 78229, United States; Recruiting
Steven R Pliszka, MD, Phone: 210-567-5475, Email: pliszka@uthscsa.edu
Candy Rhine, Phone: 210-567-0859, Email: rhine@uthscsa.edu
Additional Information
Related publications: Bush G, Spencer TJ, Holmes J, Shin LM, Valera EM, Seidman LJ, Makris N, Surman C, Aleardi M, Mick E, Biederman J. Functional magnetic resonance imaging of methylphenidate and placebo in attention-deficit/hyperactivity disorder during the multi-source interference task. Arch Gen Psychiatry. 2008 Jan;65(1):102-14. Pliszka SR, Glahn DC, Semrud-Clikeman M, Franklin C, Perez R 3rd, Xiong J, Liotti M. Neuroimaging of inhibitory control areas in children with attention deficit hyperactivity disorder who were treatment naive or in long-term treatment. Am J Psychiatry. 2006 Jun;163(6):1052-60.
Starting date: November 2008
Ending date: January 2010
Last updated: April 10, 2009
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