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Brain Dopamine Function in Adults With ADHD (Brookhaven)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring Brookhaven, ADHD, Dopamine, methylphenidate, PET

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCI Child Development Center

Outcomes

Primary Outcome Measures

Two PET scans.One at baseline and the second a year later.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2007
Last Updated
April 6, 2011
Sponsor
University of California, Irvine
Collaborators
Icahn School of Medicine at Mount Sinai, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00580814
Brief Title
Brain Dopamine Function in Adults With ADHD
Acronym
Brookhaven
Official Title
Brain Dopamine Function in Adults With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Irvine
Collaborators
Icahn School of Medicine at Mount Sinai, Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Brookhaven, ADHD, Dopamine, methylphenidate, PET

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
Methylphenidate
Primary Outcome Measure Information:
Title
Two PET scans.One at baseline and the second a year later.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Wigal, Ph.D.
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI Child Development Center
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
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Brain Dopamine Function in Adults With ADHD

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