Phase 4 N=43 Randomized Triple-blind

Neuroimaging of the Effects of Concerta in the Treatment of ADHD

Attention Deficit Disorder With Hyperactivity

Bottom Line

View on ClinicalTrials.gov: NCT00778310 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo — 1.79; 0.58; 1.43; 0.77 Face-Shape BOLD signal difference

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: methylphenidate-OROS (Drug); Placebo (Drug)
Age: Pediatric, Adult · 9+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center at San Antonio
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo	1.79; 0.58; 1.43; 0.77; 1.46; 1.64	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00778310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.