Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With OROS Methylphenidate
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: OROS methylphenidate (Drug); No intervention (Other)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Paul Hammerness, MD, Principal Investigator, Affiliation: MGH
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.
Clinical Details
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
Study design: Other, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: H MRS Scan results
Detailed description:
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
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States
Additional Information
Starting date: November 2006
Last updated: January 11, 2008
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