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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
History of Changes
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
 Drug: Methylphenidate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Brain Dopamine Function in Adults With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Two PET scans.One at baseline and the second a year later. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: February 2006
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methylphenidate
    Methylphenidate
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580814

Locations
United States, California
UCI Child Development Center
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Mount Sinai School of Medicine
Duke University
Investigators
Principal Investigator: Tim Wigal, Ph.D. UC Irvine
  More Information

No publications provided

Responsible Party: Brookhaven National Laboratory, Stonybrook State University of New York
ClinicalTrials.gov Identifier: NCT00580814     History of Changes
Other Study ID Numbers: CORIHS ID# 20055906
Study First Received: October 4, 2007
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Brookhaven
ADHD
Dopamine
methylphenidate
PET

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dopamine
Dopamine Agents
Methylphenidate
Cardiotonic Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2012