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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The primary objective of this study is to evaluate the Binding Potential in subjects with ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be used to differentiate adults with ADHD from healthy control subjects.
This protocol seeks to replicate and extend our investigation of DAT binding in adults with ADHD with specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| un-medicated subjects with ADHD |
| ||
| subjects without ADHD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET imaging using C-11 altropane as the ligand. | Radiation | A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus. |
| Measure | Description | Time Frame |
|---|---|---|
| The DAT receptor occupancy of OROS MPH and Metadate CD in adults with and without ADHD using PET scanning with C-11 Altropane. | PET imaging will be acquired using either a HR+ or Siemens Biograph 64 PET/CT camera. | Subjects will lie still in the PET camera for a 90 minute period. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological tests | Cognitive-neuropsychological functioning will be examined by selected tests that are thought to reflect basic deficits in ADHD, mainly those believed to measure components of attention and prefrontal brain systems. | Examination of cognitive-neuropsychological functioning will take approximately 2.5 hours to complete. |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator
Scores of Baseline Scales:
Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)(Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)(Beck, Ward et al. 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale)(Hamilton 1959)
History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
Any clinically significant chronic medical condition, in the judgement of the investigator.
Mental impairment as evidenced by an I.Q. <75.
Subject must be off any investigational drug for at least 4 weeks prior to the start of the study.
Exposure to dopamine receptor antagonists, including stimulant medications (e.g. methylphenidate) or buproprion within the previous three (3) months to the start of the study.
Exposure to non-stimulant ADHD medications (e.g. atomoxetine) within the previous 4 weeks to the start of the study.
Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
Subjects receiving psychotropic medication.
Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG, outside of normal limits.
Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
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200 un-medicated subjects with ADHD and 100 subjects without ADHD will be recruited sequentially. No individual will be excluded based on gender, race, or ethnicity.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Spencer, MD | Massachusetts General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23273726 | Derived | Spencer TJ, Biederman J, Faraone SV, Madras BK, Bonab AA, Dougherty DD, Batchelder H, Clarke A, Fischman AJ. Functional genomics of attention-deficit/hyperactivity disorder (ADHD) risk alleles on dopamine transporter binding in ADHD and healthy control subjects. Biol Psychiatry. 2013 Jul 15;74(2):84-9. doi: 10.1016/j.biopsych.2012.11.010. Epub 2012 Dec 27. |
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A sample of blood (2 tablespoons) will be drawn from all subjects.
| Genotyping | Genotyping will be performed using a custom markers for dopamine-related genes (DAT, DRD4-7, D2, and DBH). | A sample of blood (2 tablespoons) will be drawn from all subjects. |
| 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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