Neuroimaging of the Effects of Concerta in the Treatment of ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): methylphenidate-OROS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Keywords: Attention Deficit Disorder with Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD