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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Duke University | OTHER |
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The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylphenidate | Experimental | intervention is methylphenidate once daily for 12 months, doses individually titrated |
|
| No medication | No Intervention | no methylphenidate treatment for non ADHD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: methylphenidate treatment | Drug | subjects received mehtylphenidate treatment for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| DAT Availability | Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention. The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands. The dynamic PET scans were started immediately after injection of [11C]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged [11C] cocaine in plasma for quantification of DAT availability. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Wigal, Ph.D. | UC Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Child Development Center | Irvine | California | 92612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23696790 | Background | Wang GJ, Volkow ND, Wigal T, Kollins SH, Newcorn JH, Telang F, Logan J, Jayne M, Wong CT, Han H, Fowler JS, Zhu W, Swanson JM. Long-term stimulant treatment affects brain dopamine transporter level in patients with attention deficit hyperactive disorder. PLoS One. 2013 May 15;8(5):e63023. doi: 10.1371/journal.pone.0063023. Print 2013. | |
| Result | Volkow, N.d., Wand, G., Kollins., Wigal, T., Newcorn, J., Telang, F., Fowler, J., Solanto, M.V., Logan, J., Ma, Y., Pradham. K., Wong, C., Zhu, W. & Swanson, J.M. Dopamine Reward Pathway Disrupted in Patients with ADHD: Therapeutic Implications, Journal of American Medical Association. |
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Subjects were interviewed to determine mental health diagnosis of ADHD with symptoms existing since childhood. All other psychiatric diagnoses were exclusionary as was neurological or cerebral disease. Healthy controls were also recruited. All subjects were then scheduled for scans at Brookhaven and ADHD subjects then recieved one year of meds.
Subjects were recruited at 3 sites from 2004 - 2008. They were all consented to the protocol before any study procedures were done.Subjects were recruited through flyers and newspaper ads. They were seen at medical clinics and ADHD diagnosis was confirmed. All subjects were treatment naive for stimulant medications.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate Treatment | methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year. |
| FG001 | no Intervention | no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline PET Scans at Brookhaven |
| |||||||||||||
| One Year of Treatment or no Intervention |
| |||||||||||||
| Repeated PET Scans |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate Treatment | methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year. |
| BG001 | no Intervention | no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months |
| 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 | DAT Availability | Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention. The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands. The dynamic PET scans were started immediately after injection of [11C]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged [11C] cocaine in plasma for quantification of DAT availability. | DAT availability was measured as ratio of distribution volume in striatum to cerebellum -1 (BPND-1), which represents number of transporters free to bind radiotracer. Distribution volume ratio images were transformed into images by computing total distribution volume in each pixel and dividing by distribution volume in cerebellum. Regions of interest in striatum (caudate, putamen, ventral striatum) were drawn on an averaged emission image (10 to 60 minutes for [11C] cocaine). | Posted | Mean | Standard Deviation | ratio | 1 year |
1 year
Subjects seen monthly for one year.
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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 | Methylphenidate Treatment | methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year. |
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The length of the study resulted in the loss of a number of subjects in both arms of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Wigal, Ph.D., director UCI CHild Development Center | UCaliforniaIrvine | 949-824-1812 | tlwigal@uci.edu |
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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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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| PET scan of DAT availability | All subjects who are enrolled will receive PET scans at Brookhaven to examine DAT availability | Number | participants |
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|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | no Intervention | no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months | 0 | 20 | 0 | 20 | 0 | 20 |
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