Clinical trial NCT00580814: Brain Dopamine Function in Adults With ADHD
Official title: Brain Dopamine Function in Adults With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Brookhaven
ADHD
Dopamine
methylphenidate
PET
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Duke University
First posted: 2007-12-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Must give informed consent
* Must be between the ages of 18 and 45 years old.
* Must have a confirmed diagnosis of ADHD
* Must have scored on a rating scale that indicate a significant level of symptom severity.
* Must have a childhood history of ADHD must be documented using established test criteria.
* Must have had no previous medication treatment for ADHD except for a short term treatment period of less than three months, which should have occurred at least six months prior to the study.
* Must have an interest in receiving long-term medication treatment for ADHD.

Exclusion Criteria:

* Must not test positive for psychoactive drugs during a urine drug screen.
* Must not be pregnant.
* Must not be breastfeeding.
* Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
* Must have no past or present history of a psychiatric disorder except ADHD.
* Must have no medical illness that may affect brain function.
* Must not have taken medication that may affect brain function.
* Must not have had head trauma with loss of consciousness (\> 30 minutes).
* Must not have significant anxiety or depression as determined by an established test.
* Must have no history of a significant learning disability.
* Must have no history of cardiovascular or endocrinological disease.
* Must have no history of coagulation disorder.
* Must have no history of sensitivity to lidocaine and/or prilocaine.
* Must have no history of claustrophobia.
* Contraindication to MRI environment (presence of any implanted metallic objects such as cardiac/neural pacemakers, defibrillators, aneurysm clips, certain heart valves, spinal nerve stimulators, artificial joints/limbs, shrapnel/bullets, metal fragments in their eyes, cochlear implants, hearing aids, dental implants).
* Must have no history of glaucoma.

Primary outcomes:
measure: DAT Availability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Child Development Center
state: California
Study officials:
affiliation: UC Irvine
name: Tim Wigal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.