Phase 4
Completed N=39
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
Source: ClinicalTrials.gov NCT00593112 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino) — 1.50; 1.56 MRS Ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino) |
1.50; 1.56 | — |
| PRIMARY H MRS Scan Results - Glutamine (Gln)/Ino |
1.08; 1.02 | — |
| PRIMARY H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino |
2.58; 2.59 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, 12-17 years of age.
- ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.
- Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.
- 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.
- 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
- Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Organic brain disorders or mental retardation (I.Q. <75).
- Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
- 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.
- Severe phobia of being in small, enclosed spaces.
- 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.
Data sourced from ClinicalTrials.gov (NCT00593112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.