Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: OROS methylphenidate; No intervention
Intervention description: Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.; No intervention
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HMRS Scanning; ADHD; Child; Adolescent; HMRS Scans

Summary:

      This will be an open label study using daily does of up to 126mg/day of Concerta in the
      treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD.
      Specific hypotheses are as follows:

      Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC
      Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine +
      phosphocreatine (Glu/Cr) than matched HCS.

      Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC
      Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects, 12-17 years of age.

          2. ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in
             ADHD Youth with CONCERTA Protocol"; #2003-P-001313.

          3. Control subjects must not meet full DSM-IV criteria for Attention Deficit
             Hyperactivity Disorder, or any other current major psychiatric disorder.

          4. Each subject and his/her authorized legal representative must understand the nature of
             this proposed study, and must sign informed consent and informed assent documents.

          5. Subject and parent must have a level of understanding sufficient to communicate
             intelligently with the investigator and study coordinator, and to cooperate with study
             procedures.

        Exclusion Criteria:

          1. Clinically significant chronic medical condition including hepatic, renal,
             gastroenterologic, respiratory, cardiovascular (including ischemic heart disease),
             endocrinologic, neurologic, immunologic, or hematologic disease.

          2. Organic brain disorders or mental retardation (I.Q. <75).

          3. Contraindication to MRI including presence of metal or surgical devices (plates,
             implants, braces or other items).

          4. Pregnancy; women of child bearing potential must be using a medically approved method
             of birth control. Women of child bearing potential will receive a urinary pregnancy
             test prior to each MR scanning session.

          5. Severe phobia of being in small, enclosed spaces.

          6. Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild will not be eligible to participate in the
             treatment arm of the study.