Neuroimaging of the Effects of Concerta in the Treatment of ADHD

NCT00778310 | Completed Phase 4 Results

• 1 other identifier: CONCERTAATT4087
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Attention Deficit Disorder with Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD

Outcome Measures

Primary Outcomes (1)

• Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo

  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

Study Arms (2)

Concerta

EXPERIMENTAL

The subject will be administered their usual dose of Concerta the morning of the FMRI scan in a double blind fashion

Drug: methylphenidate-OROS

Placebo

PLACEBO COMPARATOR

The subject will be administered a placebo the morning of the FMRI scan in a double blind fashion

Drug: Placebo

Interventions

methylphenidate-OROS DRUG

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.

Concerta

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Dept of Psychiatry, UTHSCSA

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• 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. doi: 10.1001/archgenpsychiatry.2007.16.

  PMID: 18180434 BACKGROUND

• 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. doi: 10.1176/ajp.2006.163.6.1052.

  PMID: 16741206 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No typically developing control group compared to either the adult or child group.

Results Point of Contact

• Title: Steven R. Pliszka MD
• Organization: University of Texas Health Science Center at San Antonio

pliszka@uthscsa.edu

210-567-5475

Study Officials

• Steven R Pliszka, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 13, 2012
• Results First Posted: July 13, 2012

Record last verified: 2012-04

Locations

US (1)