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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OROS Methylphenidate | Experimental |
| |
| Control | Other | Healthy Volunteer Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS methylphenidate | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino) | 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. | after 6 weeks Concerta treatment |
| H MRS Scan Results - Glutamine (Gln)/Ino | 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. | after 6 weeks Concerta treatment |
| H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino | 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. | after 6 weeks Concerta treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Hammerness, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | OROS Methylphenidate | OROS = Osmotic-controlled Release Oral delivery System |
| FG001 | Control | Healthy Volunteer Control group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OROS Methylphenidate | OROS = Osmotic-controlled Release Oral delivery System |
| BG001 | Control | Healthy Volunteer Control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino) | 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. | Seven subjects who completed the protocol were not included due to a lack of baseline comparison. | Posted | Mean | Standard Deviation | MRS Ratio | after 6 weeks Concerta treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OROS Methylphenidate | OROS = Osmotic-controlled Release Oral delivery System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Hammerness, M.D. | Massachusetts General Hospital | 617-503-1040 | phammerness@partners.org |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| No intervention | Other | No intervention |
|
| Unreadable Scan |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy Volunteer Control group
|
|
| Primary | H MRS Scan Results - Glutamine (Gln)/Ino | 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. | Seven subjects who completed the protocol were not included due to a lack of baseline comparison. | Posted | Mean | Standard Deviation | MRS Ratios | after 6 weeks Concerta treatment |
|
|
|
| Primary | H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino | 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. | Seven subjects who completed the protocol were not included due to a lack of baseline comparison. | Posted | Mean | Standard Deviation | MRS Ratio | after 6 weeks Concerta treatment |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Control | Healthy Volunteer Control group | 0 | 12 | 0 | 12 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |