Neuroimaging of the Effects of Concerta in the Treatment of ADHD

Completed · Phase 4 · Has a placebo group

Conditions studied: Attention Deficit Disorder With Hyperactivity

In brief

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.

Key facts

Study ID

NCT00778310

Run by

The University of Texas Health Science Center at San Antonio

People needed

76

Starts

2008-11-01

Expected to finish

2010-12-01

Last updated by the study team

2012-07-13

Who can join

Age: 9 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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