Brain Dopamine Function in Adults With ADHD

NCT00580814 | Completed Results

• 1 other identifier: 20054659
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Brookhaven; ADHD; Dopamine; methylphenidate; PET

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

methylphenidate

EXPERIMENTAL

intervention is methylphenidate once daily for 12 months, doses individually titrated

Drug: Experimental: methylphenidate treatment

No medication

NO INTERVENTION

no methylphenidate treatment for non ADHD

Interventions

Experimental: methylphenidate treatment DRUG

subjects received mehtylphenidate treatment for 12 months

Also known as: methylphenidate once daily for 12 months, doses individually titrated for efficacy

methylphenidate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Irvine: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Duke University: collaborator

Study Sites (1)

UCI Child Development Center

Irvine, California, 92612, United States

Location

Related Publications (2)

• 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.

  PMID: 23696790 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The length of the study resulted in the loss of a number of subjects in both arms of the study.

Results Point of Contact

• Title: Tim Wigal, Ph.D., director UCI CHild Development Center
• Organization: UCaliforniaIrvine

tlwigal@uci.edu

949-824-1812

Study Officials

• Tim Wigal, Ph.D.

  UC Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Pediatrics

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: December 27, 2007
• Study Start: February 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Locations

US (1)