Brain Dopamine Function in Adults With ADHD (Brookhaven)

This study has been completed.
Sponsor:
Collaborators:
Mount Sinai School of Medicine
Duke University
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580814
First received: October 4, 2007
Last updated: April 6, 2011
Last verified: April 2011

October 4, 2007
April 6, 2011
February 2006
March 2009   (final data collection date for primary outcome measure)
Two PET scans.One at baseline and the second a year later. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00580814 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Brain Dopamine Function in Adults With ADHD
Brain Dopamine Function in Adults With ADHD

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Methylphenidate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580814
CORIHS ID# 20055906
No
Brookhaven National Laboratory, Stonybrook State University of New York
University of California, Irvine
  • Mount Sinai School of Medicine
  • Duke University
Principal Investigator: Tim Wigal, Ph.D. UC Irvine
University of California, Irvine
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP