Phase 4
Completed N=43
Neuroimaging of the Effects of Concerta in the Treatment of ADHD
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00778310 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.