Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
NCT ID: NCT00593112
Last Updated: 2012-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
39 participants
INTERVENTIONAL
2006-11-30
2009-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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OROS Methylphenidate
OROS methylphenidate
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.
Control
Healthy Volunteer Control group
No intervention
No intervention
Interventions
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OROS methylphenidate
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
No intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
18 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Paul Hammerness, MD
Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD
Principal Investigators
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Paul Hammerness, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Cambridge, Massachusetts, United States
Countries
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Related Links
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Related Info
Other Identifiers
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2005-P-002180
Identifier Type: -
Identifier Source: org_study_id