Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
NCT Number: 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.
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Notify Me12 year–18 year
All sexes
Interventional
Phase 4
Cambridge, Massachusetts, 02138, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Concerta
No intervention
Time frame: after 6 weeks Concerta treatment
Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.
Time frame: after 6 weeks Concerta treatment
Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.
Time frame: after 6 weeks Concerta treatment
Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)
This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.
Massachusetts General Hospital
Other
A Pilot Study of Proton Magnetic Spectroscopy in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) Before and After Treatment With Osmotic-controlled Release Oral Delivery System (OROS) Methylphenidate
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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