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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00593112 |
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.
Condition | Intervention | Phase |
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ADHD |
Drug: OROS methylphenidate Other: No intervention |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Parallel Assignment |
Official Title: | A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With OROS Methylphenidate |
Estimated Enrollment: | 20 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: 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.
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2
Healthy Volunteer Control group
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Other: No intervention
No intervention
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The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20 controls matched by age and gender. We also will scan 20 children with ADHD between the ages of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of Concerta. These 20 children will be scanned once while on medication and once while off medication
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Paul Hammerness, MD | MGH |
Responsible Party: | MGH ( Paul Hammerness, MD ) |
Study ID Numbers: | 2005-P-002180 |
Study First Received: | December 28, 2007 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00593112 |
Health Authority: | United States: Institutional Review Board |
HMRS Scanning ADHD Child Adolescent HMRS Scans |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Attention Deficit and Disruptive Behavior Disorders Hyperkinesis |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Stimulants Dopamine Agents Central Nervous System Agents Pharmacologic Actions |