Brain Dopamine Function in Adults With ADHD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- DAT Availability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
No medication
no methylphenidate treatment for non ADHD
methylphenidate
intervention is methylphenidate once daily for 12 months, doses individually titrated
Intervention: Experimental: methylphenidate treatment (Drug)
Outcomes
Primary Outcomes
DAT Availability
Time Frame: 1 year
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Coleen Cunningham
Professor and Chair of Pediatrics
University of California, Irvine